Apr

2007

Class II Radiometer America Inc

Company:Radiometer America Inc.
Date of Enforcement Report:4/11/2007
Class:ll

PRODUCT
ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27, Recall # Z-0705-2007

REASON
In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.

CODE
There are no specific lot codes. The problem is associated only with customers that use the ”Safe Pico” blood sampler in conjunction with the ABL800 analyzer.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by letter dated January 16, 2007.
Manufacturer Address: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1345 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

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.

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Class II Radiometer America Inc

Amy Sellers

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