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Terminated

HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level.

FDA Recall Z-1848-2011 · Posted 2011-03-30

Recalling FirmHemo Cue, Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2010-10-07
Date Terminated2011-06-22
Product Quantity23

Reason for Recall

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.

Firm Action

Hemocue AB sent Customer Notification "Notice of Medical Device Correction on HemoCue Glucose 201 DM and HemoCue Hb 201 DM Analyzers" dated October 7, 2010, to customers notifying them of incorrect settings on error codes. The corrective action consists of an update of the configuration settings on the the affected HemoCue Glucose 201 DM and Hb 201 DM analyzers that are in the field. The affected units in the field will be corrected in accordance with a rework procedure that has been established by HemoCue AB.

Root Cause

Process control

Distribution Pattern

Worldwide distribution, including USA, and Glucose 201 DM analyzers to Norway and the Netherlands; Hb 201 DM analzyers to the Netherlands, France, Ireland, Great Britain, Poland and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041230CLINICAL LABORATORY ANALYZING SYSTEMHemocue, Inc. · 2004-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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