Recall Z-1070-2009 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA
| Date | Mar 17, 2009 (initiated Nov 25, 2008) |
| Status | Terminated |
| Reason | Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results. |
| Root cause | Process design |
| Action | Urgent: Medical Device Recall letters, dated 11/24/2008 were issued to all consignees on November 25, 2008, requesting return of affected lots to LifeScan and instructing how to obtain replacement strips free of charge. A request for sub-recall communications were made as well, and the firm posted notification on its website. Customer service and Sales account reps were provided information to address questions regarding the recall. |
| Quantity | 23,288 vials |
| Distribution | Worldwide Distribution -- USA and the Caribbean. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022724 | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc., Sep 12, 2002 |