Inc, Class IIl Radiometer America

Company: Radiometer America, Inc,
Date of Enforcement Report:8/16/2006
Class:lIl

PRODUCT
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21, Recall # Z-1325-06

REASON
ABL800 Series Blood Gas Analyzer became inoperable when the restore default setup button was touched..

CODE
Software Versions 5.21 i.e. ABL8xx 754R00xx N0xx

RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by memo and visits beginning on October 31, 2005.
Manufacturer: Radiometer Medical Aps, Bronshoj, Denmark. Firm initiated recall is complete

VOLUME OF PRODUCT IN COMMERCE
36 analyzers

DISTRIBUTION
Nationwide and Internationally

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.