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Company: Dade Behring Marburg GMBH MarburgDate of Enforcement Report: 9/5/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software version 2.2. REASON: Leak of piston pump valve introduces air bubbles. CODES: Model OVIO03 Version 2.2 MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, INC., Newark, DE., by letter...
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Company: DADE BEHRING, INCDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software, 5.1 REASON: Incorrect low results for a number of patient samples. CODE: Version 5.1 MANUFACTURER: DADE BEHRING, INC., NEWARK, DE RECALLED BY: Manufacturer, by letter 4/9/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION:...
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Company: Medica Corp.Date of Enforcement Report: 9/5/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0951-1 EasyBlood Gas Analyzer. REASON: PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg. CODES: EasyBlood Gas Analyzers with Software version below M4.20. MANUFACTURER/RECALLING FIRM: Medica Corp., Bedford, MA. RECALLED BY: Manufacturer, by fax on 8/15/00....
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Company: Siemens Medical Systems, Inc.Date of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0769-1 – Z-0771-1 E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 CODES: a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and...
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Company: Lee Memorial Health System Date: 8/27/2001 Product: unlicensed blood banks The inspection revealed failure of your blood bank to adequately determine the suitability of persons to serve as whole blood donors. One donor (unit [redacted]) tested repeatedly reactive for HIV 1-2 in screening tests-performed on March 21, 2001 and was never placed in deferral....
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Company: Lee Memorial Health SystemDate: 8/27/01 Product: Blood bank The inspection revealed failure of your blood bank to adequately determine the suitability of persons to serve as whole blood donors. One donor (unit _____) tested repeatedly reactive for HIV 1-2 in screening tests performed on March 21, 2001 and was never placed in deferral. Donor...
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DATE RECALL INITIATED< br> August 24, 2001 PRODUCT / LOT NUMBER / EXPIRATION DATE: FlexiLab Blood Bank and Blood Donor Software, Software versions 5.2, 5.23, and 5.3 MANUFACTURER: Sunquest Information Systems, Inc. Tucson, AZ REASON: A software defect has the potential to result in blood components/derivates reaching inventory “Available Inventory Status” without a product testing...
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Company: DADE BEHRING, INC.Date of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software version 5.1 REASON: Incorrect low results for a number of patient samples MANUFACTURER/RECALLING FIRM: DADE BEHRING, INC., Newark, DE RECALLED BY: Manufacturer, by letter on 4/9/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION:...
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Company: SONOSITE, INCDate of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-868-1, Sonosite 180 – portable, software controlled ultrasound system intended for use with a variety of transducers to perform a variety of scans and measurements/calculations for the abdomen, pediatric scans, general cardiac, GYN/infertility, obstetrics. Code: Sonosite units with the following software...
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Company: SUNQUEST INFORMATION SYSTEMS, INCDate of Enforcement Report: 8/22/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0733-1, FlexiLab Laboratory Information System Version 5.2, 5.23, and 5.3 interfaced with Anatomic Pathology Lab Access Transcription Workstation. REASON: Software glitch MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., TUCSON, AZ RECALLED BY: A temporary procedural workaround was communicated to all...
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Company: SUNQUEST INFORMATION SYSTEMS, INCDate of Enforcement Report Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0735-1, FlexiLab Laboratory Information System, Version 5.23 REASON: Software anomaly MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., Tucson AZ RECALLED BY: A temporary procedural workaround was communicated to all affected customers in Product Safety Notice PSN-01-L18, June 8, 2001. FIRM INITIATED...
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Company: ALARIS MEDICAL SYSTEMS, INCDate of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-748-1, Model PC-1 A one channel, general purpose, infusion pump, 220V CE Marked, International only (Software version 8.12 and 8.13) REASON: Motor stall MANUFACTURER/RECALLING FIRM: ALARIS MEDICAL SYSTEMS, INC., San Diego, CA RECALLED BY: International mailings are being coordinated...
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Company: DADE BEHRING MARBURGDate of Enforcement Repor: 8/22/01t Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0906-1, Behring Coagulation System (BCS) software version 2.2 REASON: Leak of piston pump valve introduces air bubbles MANUFACTURER: DADE BEHRING MARBURG, Germany RECALLED BY: DADE BEHRING, INC., GLASGOW, DE, by letter to the three accounts informing them of the problem...
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Company: Southeastern Home Oxygen Service Inc.Date: 8/7/01 Product: Medical Oxygen You failed to assure the adequacy of your firm’s current computer distribution tracking system. Review of 2 lots selected at random for comparison of production records with computerized tracking information revealed inconsistencies in the number of oxygen cylinders filled with those distributed. FDA District: Atlanta...
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Company: American Blood Resources AssociationDate: 7/31/01 Product: Blood Bank Deferral Software During an inspection of your facility located in Annapolis, Maryland, on June 18 through 22, 2001, Food and Drug Administration (FDA) investigators determined that you manufacture and distribute, Blood Bank Deferral Software. This software is a device within the meaning of section 201(h) of...
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Company: Kaken Pharmaceutical Co Ltd.Date: 7/27/01 Product: Drug Products Written procedures for production, process control, and laboratory operations were not always followed to assure that APIs have the appropriate quality and purity. The inspection reported numerous instances regarding the following operations which present a general practice of not following written procedures: -Stability testing -Storage of...
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Below is the classifcation rule. Note that this has been used for automated sample preparation systems of some types as well.TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES–Table of Contents Subpart C_Clinical Laboratory Instruments Sec. 862.2050 General purpose laboratory equipment labeled...
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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Detail.CFM?STANDARD__IDENTIFICATION_NO=5188
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Date Recall Initiated:July 20, 2001 Product: Solar 9500 Physiological ECG Monitor Use: To monitor patient vital signs including blood pressure, pulse, temperature, cardiac output, respiration, and anesthetic gas concentrations during surgery. This product is intended for use under the direct supervision of a licensed health care practitioner. Reason for Recall: Incorrect computer chips were installed...
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Company: SeQual Technologies Inc.Date: 7/18/01 Product: Oxygen Failure to ensure that a process whose results cannot be fully verified by subsequent inspection and testing, has been validated and approved according to established procedures [21 CFR 820.75(a)]. Specifically, your firm has no documented evidence that provides a high degree of assurance that the manufacturing specifications and...
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Company: Toshiba America Medical Systems, Inc.Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0690-1, Impax Technology Inc. DDS Intended use is as Diagnostic Image Display Software Model/catalog number: DS3000, CS5000, XA3000 REASON: Wrong image presents to radiologist upon database query. MANUFACTURER/RECALLING FIRM: Toshiba America Medical Systems, Inc., Tustin, CA RECALL BY:...
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Company:Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE Z-0691-1 through Z-0693-1 Software used on the Computerized Tomography Fluoroscopy CT Fluroscopy option, model numbers TSXF-003A; TSXF-003B; TSXF-003C for Aquilion (Model No. TSX-101A) and Asteion (Model No. TSX-021A) Computed Tomography Scanners REASON: X-ray generation without operator command using unusual program sequence. MANUFACTURER/RECALLING FIRM:...
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RECALL NUMBER, PRODUCT AND CODE:Company: Community Blood Center of Greater Kansas City Date of Enforcement Report: 7/11/01 Class: II B-1457-1, Red Blood Cells Units L04250, L02615, M84346, T52350, T033222,T031302, T028101, T025140, T012049, T007397 B-1458-1, Platelets, Pheresis, Units T038725, T035305, T034495 B-1459-1, Platelets Units T031302, T012049, T007397 B-1460-1, Fresh Frozen Plasma Units L04250 (divided into 4...
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Company: Paul E. Garland M.D.Date: 7/11/01 Product: Excimer Laser Medical devices used by doctors in their course of their practice to treat patients are “marketed” and “held for sale” within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). An excimer laser is a class III device under section 513(f) of the...
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Date of Enforcement Report: 7/11/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0629-1, Multi-Therapy Ambulatory Infusion Pumps sold under the following labels a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40 (English), 606000-40L (loaner pump) and 606000-40I (International) b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code 2M9832 REASON: Potential overinfusion in the Auto-Ramp mode...
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Company: Cardinal Health Inc.Date: 7/10/01 Product: Drug Products Failure to have an adequate validation procedure for computerized spreadsheets used for in-process and finished product analytical calculations. The current validation procedure uses only the values that result in within specification findings, aberrant high findings, and aberrant low findings [21 CFR 211.165(e)]. For example, SOP 644.00, QA/QC...
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Company: EP MedSystemsDate: 7/10/01 Product: Cardiac Catheters Your firm failed to validate several computer databases that are used for quality functions including your Access database, your _____ software, and your MS Excel spreadsheet program as required by 21 CFR 820.70(i). FDA District: New Jersey
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Company: SciOptic InternationalDate: 7/9/01 SciOptic has contended that the _____ could be considered as a “custom device” within the meaning of 21 CFR 812.3(b). FDA has previously informed you that the _____ is not a custom device as it does not meet the necessary criteria found in section 520(b) of the Act, or in 21...
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Company: Aventis Bio-ServicesDate: 6/29/01 Product: Blood Products There are no written procedures and controls in place to assure that the manual permanently deferred donor files are checked when determining the suitability of new donors. Not all permanently deferred donors are included in your _____ computer system. In order to verify that a new donor is...
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Company: Transplantation Research FoundationDate: 6/25/01 Product Name: Dura mater allografts Failure to establish and maintain procedures to control product that does not conform to specified requirements [21 CFR 820.90]. For example, the computer disposition records did not clearly document the destruction of unsuitable dura mater, and there are no disposition procedures addressing the segregation and...
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Company: Marshall Medical Center North Date: 6/20/01 Product name: Mammography facility Note: The wording of this noncompliance was changed in the software to incorporate several other similar noncompliance issues. The finding is specific to corrective action for a failing image score not being documented FDA District: New Orleans District
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http://www.asq.org/ed/courses/descriptions/buildsoftwareq.html
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Company: Analogic CorportationDate: 6/13/01 Class: II PRODUCT: a) Philips Tomoscan M. Recall # Z-550-1. b) Philips Tomoscan EG. Recall # Z-551-1. c) Philips Tomoscan EG. Recall # Z-552-1. REASON: The diagnostic x-ray devices fail to conform to design specifications relating to the accomplishment of their intended purpose. CODE: a) Philips Tomoscan M; b) Philips Tomoscan...
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Company: Electronic Data Systems (EDS)Enforcement Report Date: 6/13/01 Class: II PRODUCT: Defense Blood Standard System, Blood Bank Computer Software, – In use at 79 military facilities. Recall # B-897-1. REASON: Due to a defect in computer software, expired blood products that were returned, and units that were received at out of spec temperatures, were not...
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483Company: Schering-Plough Prodcuts, LLC City and Sate: Manati, Puerto Rico 00674-0486 FDA District: San Juan, Puerto Rico Dates of Inspection: 5/1/01-6/13/01 You failed to have adequate security controls for your HPLC system, once accessed by one employee is left opened and available for other personnel to gain access to the original employee’s analytical test reports....
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483Company: Schering-Plough Prodcuts, LLC City and State: Las Pierdas, PR FDA District: San Juan, Puerto Rico Dates of Inspection: 5/1-6/5-2001 You have not developed validation/qualification master plans encompassing process, cleaning computer and analytical method validation as directed by the Corporate Quality Assurance Guideline titled Master Plans for Validation/ Qualification issued 10/12/1999. You failed to have...
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/Docs/SCPRed/SoftwareCPR-Newsletter052601.PDF
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Recall of Amicus Separator Operating with Version 2.50 Software REASON: Baxter Healthcare Corporation is recalling Amicus Separators operating with version 2.50 software after discovering that the device may return an inappropriate volume of plasma to a donor during an apheresis procedure. This occurrence has been observed during single needle procedures using Amicus Separators operating with...
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The Validation Times Vol III, No. 5 May 2001 reported that James McCormack of FDA : 1. Indicated that the first two FDA Part 11 Guidances may be issued as early as June 2001. These would be the Glossary and Validation guidances. Scope would not be addressed. Other guidances would follow over a period of...
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Company: Cardiomedics, Inc. Date of Enforcement Report: 5/30/01 Class: II PRODUCT: CardiAssist External Counter Pulsation (ECP)System. Recall #Z-573-1. REASON: The screen on the unit containing software version 1.4.3 intermittently locks up. Unexpected shutdown; deletion of use for cardiogenic shock. CODES: n/a MANUFACTURER: Cardiomedics, Inc., Irvine, CA. RECALLED BY: Manufacturer, by facsimile, dated April 4, 2001,...
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Company: Instrumentation Laboratory Co. Date of Enforcement Report: 5/30/01 Class: III PRODUCT: ACL Futura Coagulation Analyzers. Recall #Z-577-1. REASON: There is a software error that may cause index file and record information to be mismatched. CODES: All Serial Numbers with software version below V3.4. MANUFACTURER: Instrumentation Laboratory Co., Lexington, MA. RECALLED BY: Manufacturer, by letters,...
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Company: Mediware Information Systems, Inc.Date: 5/29/01 REASON: The expiration date of a manufactured product may be mistakenly extended, without displaying a warning to the user, when entered under certain specific conditions. DATE RECALL INITIATED: May 29, 2001 PRODUCT / VERSIONS Hemocare Blood Bank Data Management System Software Software versions 5.1, 5.2, 5.2a, 5.2b for use...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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