Recall Z-2570-2011 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diagnostics Operations, Inc.
ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.
| Date | Jun 21, 2011 (initiated May 18, 2011) |
| Status | Terminated |
| Reason | Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that can cause test strip errors or a bias in test result that exceed the tolerance range according to EN ISO 15197. |
| Root cause | Component design/selection |
| Action | Direct accounts were notified by a Roche Diagnostics press release on 5/18/2011 that included the product's name, lot number, and information to withdraw the remaining inventory of lot 470049 from storage |
| Quantity | 27,019 units |
| Distribution | No US distribution, in France Only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.