HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level.
FDA device recall Z-1848-2011 · posted 2011-03-30 · Terminated
Recall details
- Recalling firm
- Hemo Cue, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 23
- Distribution
- 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.
- Date initiated
- 2010-10-07
- Date posted
- 2011-03-30
- Date terminated
- 2011-06-22
- Location
- Cypress, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLINICAL LABORATORY ANALYZING SYSTEM (K041230) | Hemocue, Inc. | 2004-05-20 |