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PRODUCT Architect i 2000 System. Recall #Z-906-0. REASON System allows running of samples while the automatic flushing/cleaning occurs. CODE All units, all software versions. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois, by letter on April 25, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Puerto Rico, Korea, Mexico, Canada,...Read More

Limberg Eye Center 4/17/00 Failure to maintain complete and accurate records [21 CFR 812.140(a)]. Information on some of the case report forms (CRFS) did not agree with the computerized subject records and vice versa for those records that were originally captured on the CRF and then transcribed to the computerized source records. Moreover, UCVA readings...Read More

Harper Hospital Blood Bank 4/13/00 Failure to perform/maintain computer validation [21 CFR 211.68] in that: there was no validation protocol to show how the system was tested and what were the expected outcomes; there was no documentation to identify the operator performing each significant step, date completed, whether expected outcomes were met, and management review;...Read More

Euclid Systems – contacts 4/12/00 The devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods “used in, or the facilities or controls used in the manufacture, processing, packaging, storage, or distribution of Orthokeratology (itaflurofocon B), toric, and aspheric contact lenses, are not in conformance with the Quality System...Read More

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Exmoor advised in its response that professional auditor training will be provided and that subsequent in-house training will be conducted and documented for key staff with auditing responsibilities. Furthermore, training needs will not only be assessed during appraisal and counseling sessions, but also during Quality Management Review Meetings, external audits, internal audits and corrective actions....Read More

Electric Mobility – Scooters and power chairs 4/3/00 “…Your firm did not validate your _____ computer system which is used for quality control data, order entry and inventory functions. [21 CFR 820.70(i)” SoftwareCPR keywords: production software validationRead More

With the permission of AAMI attached is a pdf of the AAMI newsletter article summarizing the software session of the March 2000 International Software Standards Conference. AAMI 300 software articleRead More

PRODUCT Roche Hitachi 914 Chemistry Analyzer, used for diagnostic testing for routine and specialty chemistry analytes. Recall #Z-613-0. REASON There is a potential for mismatch of sample identification information and results on this version of software. CODE Catalog number 914000. All units with software version 3.0. MANFACTURER/SOFTWARE SITE Roche Diagnostic Corporation, Indianapolis, Indiana. RECALLED BY...Read More

PRODUCT Roche/Hitachi 917 Disk System Chemistry Analyzer, Catalog #917000. Recall #Z-612-0. REASON There is a potential for mismatch of sample identification information and results on all versions of software. CODE All units/software versions. MANFACTURER/SOFTWARE SITE/SOFTWARE SITE: Hitachi Instruments Division, Ibari-ken, 312 Japan. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter dated March 17, 2000....Read More

At a half-day breakout session on the AAMI Medical Device Software Standard, the HIMA Conformance Assessment Tool, UL 1998, the FDA Off-the-shelf software guidance, and other software standards and policy initiatives for the medical device industry was presented as part of the annual AAMI International Standards Conference. FDA and several industry speakers participated. John Murray,...Read More

St. Joseph’s Hospital and Medical Center Blood Bank 3/16/00″…6. Inadequate computer security in that employees have access to functions they are not qualified to perform. For example, Technical Assistants (TA) have access to the Blood Order Processing function, Blood Label Check function and Blood Product Testing function, although they are not qualified to perform the...Read More

PRODUCT a) Precision Link Blood Glucose Data Management System Software Version 2.0 and 2.1; b) Precision Link Plus Data Management Software Version 1.0. The program extracts test results from glucose monitors and converts these results into charts, graphs, and reports. It provides information to monitor diet, exercise, and medication. Recall #Z-913/914-0. REASON Glucose values greater...Read More

Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, the _____ used to ____ in _____, has not been validated, to assure it is...Read More

Thoratec Laboratories 3/10/00″..4. .The implementation of corrective and preventative action (CAPA) procedures at your firm is incomplete in that your procedures do not include reference to the Access electronic database. This database captures information from sources such as complaints and nonconformance reports for use during management reviews. In addition, battery assembly defects, such as loose...Read More

PRODUCT Fixer Image Scan Editing Utility, Version 3.0, intended to allow the user to remove spurious image slices from a scan. Recall #Z-784-0. REASON Fixer 3.0 may provide inconsistent results if a file is changed and saved twice in the same session. CODE Fixer Software Utility Version 3.0 MANUFACTURER Radionics, Inc., Burlington, Massachusetts. RECALLED BY...Read More

PRODUCT MINICAP XP Workstations, using Baseline 8.5 software, for Computed Tomography SPECT studies with gamma cameras. Recall #Z-515-0. REASON During 360 degree SPECT, the resulting image will appear flipped left to right. CODE All Marconi MINICAP XP workstations using the Baseline 8.5 software. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY Manufacturer, by...Read More

PRODUCT SoftBank LIS or Softbank Laboratory Information System. Recall #B-692-0. REASON There is no way of assuring that ADT-Interface transactions will always include correct patient data. CODE All versions installed in computer systems. MANFACTURER Soft Computer Consultants, Palm Harbor, Florida. RECALLED BY Manufacturer, by letters dated February 28, 2000, followed by visit. Firm-initiated field correction...Read More

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PRODUCT Magnetom 42 SP Magnetic Resonance Imaging System with Software Version Number 2A2.7B. Computer aided medical device generates magnetic field resulting in a digital image of the body: a) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 89 69 131 (SP-A); b) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 87-29-485 (SP). Recall...Read More

All Architect I System Processing Modules with Software Versions1.0 and 1.01. Recall #Z-910-9. REASON The device may report incorrect results for diluted samples; and/or when used with the Laboratory Information System or Host Information Systems, the system may incorrectly associate test results with patient ID or incorrectly associate control results with patient records. CODE List...Read More

2/24/00 Class II PRODUCT Aeroset Assay Disks, V3.0 Conventional Units, used as a software diskette to upgrade the Aeroset System, which is a clinical chemistry analyzer, used for in-vitro diagnostic tests. Recall #Z-488-0. REASON The disks are improperly duplicated and contain software that will install System International (SI) units, rather than conventional units as labeled....Read More

2/21/00 Class II PRODUCT Aeroset Analyzer, used for in-vitro diagnostic tests. Recall #Z-489-0. REASON Under certain washing conditions, software error causes erratic urine creatinine results. CODE All Codes. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter dated February 21, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 176 analyzers were...Read More

REASON Failure to correctly re-calculate drug dosage using saved Drug Dosage Data. PRODUCT Infinity Modular Bedside Monitors, Models SC7000, SC8000, SC9000, SC9000XL, intended for adult, pediatric, and neonatal monitoring of clinical environment. Recall #Z-399/401-0. CODE Infinity Modular Monitors: SC7000, SC8000, SC9000, SC9000XL with software versions VEO, VEO.1 or VEO.2 MANUFACTURER Siemens Medical Systems, Inc., Danvers,...Read More

Individual Monitoring Systems -Electroencephalogry 2/11/00 “…Failure to validate computer software for its intended use. For example, your firm has not validated the software used to perform sensitivity calibration of the ActiTrac device. “ SoftwareCPR keywords: production software validation.Read More

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REASON Potential for incorrect Pediatric Reports–A software problem. PRODUCT a) 2-way MainFrame Interface Software Version 22.20; b) Pediatric Therapy Guide Version 4.10. Recall #Z-405/406-0. CODE Part Numbers: 9800-2666 and 9800-0630; Catalog Numbers: B1018-15 and B1011-30. MANUFACTURER Dade Microscan Inc., West Sacramento, California. RECALLED BY Manufacturer, by letter on February 4, 2000. Firm-initiated field correction ongoing....Read More

REASON Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter. PRODUCT Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI. Recall #Z-412-0. CODE Serial Numbers: AF212E, BA109P, BA218P, BA103P, AF165E, AF157EU, BA183P, BA118P, BA182P, BA164D, BA178P, BA114P, BA225P, BA187P, AF113EU, BB104P, BA110P, BA131D, and BA192D. MANUFACTURER...Read More

The Device Quality System Regulation (GMP) explicitly requires signatures in the following places: The sections of the regulation which specifically require signatures are: · Sec. 820.30 Design controls.c & d · Sec. 820.40 Document controls a & b · Sec. 820.75 Process validation a · Sec. 820.80 Receiving, in-process, and finished device acceptance d&e. ·...Read More

The Drug GMPs explicitly require signatures in the following places: 211.186 master prod & control recs 211.182 Equipment cleaning & use logs 211.188 batch prod & control recs 211.194 laboratory recs (perform & review) Policy guides and enforcements practices indicate that by interpertation FDA expects signatures on specific records and procedures including any places where...Read More

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Compnay: SOL PharmaceuticalsProduct: Active pharmaceutical ingredients Poduct Category: Human Drugs Date: 1/21/200 In addition, our investigative team found it impossible to trace computer generated …because they were not date stamped.Read More

1/13/00 Class II PRODUCT Alycon Analyzers, automated chemistry analyzers for in-vitro diagnostic use: a) Alycon Analyzer 300; b) Alycon Analyzer 300i. Recall #Z- 462/463-0. REASON Software program errors cause incorrect association between patient and the patient results. CODE All codes. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter dated January 13, 2000....Read More

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1/8/00 Class III recall PRODUCT Software for Pulmonary Function Testing System: a) BreezePF v3.8 Software, Catalog No. 147536-003; b) BreezePF v3.8A Software, Catalog No. 147570-003. Recall #Z-450/451-0. REASON An anomaly has been discovered in the software that can cause confusion on the selection of which FEV1/FVC ratio is selected for diagnostic reporting. The problem only...Read More

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The Medical Device and Diagnositc Industry periodical occassionally prints software articles oriented to Medical Device Manufacturers. To see their index of these articles by year, view the following link: MDDI Software ArticlesRead More

REASON Software error in Vitros ECi Immunodignostic system. PRODUCT Vitros Immunodiagnostic System, a random access immunodiagnostic analyzer for quantitative and qualitative determination of analytes in human specimens. Recall #Z-360-0. CODE Catalog #8633893, Serial #30000054-30001120. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by letters dated December 28, 1999, and January 13, 2000, and...Read More

Diasorin, Saluggia Italy 23-Dec-99 production/QC software validation for reagents”8. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use [21 CFR 820.70(g)] in that the Gamma Counter Data Transfer Validation, dated March 31. 1999. did not...Read More

REASON Software may incorrectly link previous assay results to a different patient ID. PRODUCT Chiron Diagnostics Automated Chemiluminescence System, Model ADVIA:CENTAUR for the quantitative determination of various in vitro diagnostic assays using direct chemiluminescent technology. Recall #Z-358/359-0. CODE Catalog Numbers: 114564, 572561, 572562, 572563, 572564, and 572566. All ADVIA:Centaur Immunoassay Analyzers with software versions 2.01...Read More

7. Failure to maintain complete and adequate written SOPS that reflect current bloodbank operations as requiredby21 CFR 606.100(b) and 606.60. For example, with respect to the computer system in use, there were no SOPS available for security procedures for unauthorized access, review of the system and correction of errors, and control of changes in hardware...Read More

PRODUCT AcQ Plan, 3-D Radiation Therapy Treatment Planning System (software), a software option for the Computed Tomography (CT) Scanners. Recall #Z-300-0. REASON Software anomaly causes the isocenter shift to be labeled incorrectly. CODE All units using the AcQPlan Therapy Planning software version 4.04 are affected. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY...Read More

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3d) Standard operating procedure Routine Release of Crossmatched Blood and Blood Products has not been updated to include computter operations utilizing xxx Blood Bank and Blood Donor Computer System versionyyyy. Specifically, the procedure does not include what type of second verification of information entered into the computer should be performed when blood products are released...Read More

PRODUCT Mini-Med MMT-508 Insulin Pump, indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Recall #Z-288-0. REASON The pump’s software has an error in which the current basal rate profile indicated on the pump display, was a rate programmed for earlier in...Read More

Status of FDA permission requirements for Blood Bank establishment use of electronic crossmatch as of November 18, 1999: Because 21 CFR 606.151 requires a serologic crossmatch those hospitals (all hospitals) who wish to use the electronic crossmatch must apply for a variance to 21 CFR 606.151 (as allowed by 21 CFR 640.120) to gain written...Read More

Failure to validate the EtO sterilization process for ATI plasma exchange tubing setsand off-the-shelf software for compiling clinical trial data. Also there are no procedures established and maintained for monitoring and controlling the process parameters for the ATI plasma exchange tubing sets to ensure that specified requirements are met as required by 21 CFR 820.75....Read More