Recall Z-1849-2011 ยท GKR System, Hemoglobin, Automated
Hemo Cue, Inc.
HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination.
| Date | Mar 30, 2011 (initiated Oct 7, 2010) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 79 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041234 | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM Hemocue, Inc., Jun 10, 2004 |