Class Il Radiometer America Inc

Company:Radiometer America Inc.
Date of Enforcement Report:8/16/2006
Class:lI

PRODUCT
a) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer,
ABL-700 series, Recall # Z-1317-06;
b) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer,
ABL-800 series, Recall # Z-1318-06

REASON
Software defect. pO2 and pCO2 sample test results run on the firm’s ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase..

CODE
a) All analyzers manufactured from 1/1999-12/2005. The devices
contain serial numbers 902-441RxxxNxxx. The Rxxx number
denotes manufacturing run, and the Nxxx number denotes the
individual instrument within the run;
b) All analyzers manufactured from 1/2005-10/31/2005. The devices
contain serial numbers 902-441RxxxNxxx. The Rxxx number
denotes manufacturing run, and the Nxxx number denotes the
individual instrument within the run.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc, WestlakeOH, by letter on June 17, 2005
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
Series 700 — 1,635 Analyzers;
Series 800 — 108 Analyzers

DISTRIBUTION
Nationwide

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.