Apr

2011

Cl ll HEMOCUE AB Analyzers

Company: Hemo Cue, Inc.
Date of Enforcement Report 4/6/2011
Class ll:

PRODUCT
1) HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level. Recall # Z-1848-2011;

2) HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination. Recall # Z-1849-2011

REASON
Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance of the analyzer. Possible incorrect results.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hemo Cue, Inc., Cypress, CA, by letter dated October 7, 2010.
Manufacturer: Hemocue AB, Angelholm, Sweden Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
Glucose 201 DM analyzers (23); Hb 201 DM analyzers (79)

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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Cl ll HEMOCUE AB Analyzers

Amy Sellers

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