Radiometer ABL800 analyzer with FLEXQ module Cl II

Company:Radiometer America
Date of Enforcement Report 12/20/2017
Class lI:

PRODUCT

ABL800 analyzer with FLEXQ module.Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) – in vitro testing of samples
Recall Number Z-0231-2018

REASON
Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.

RECALLING FIRM/MANUFACTURER
Radiometer America, Brea, CA on 10/24/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
1,749 analyze

DISTRIBUTION
Nationwide and Canada

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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.

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