Recall Z-1370-05 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diagnostics Corp.
ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.
| Date | Aug 13, 2005 (initiated Jun 7, 2005) |
| Status | Terminated |
| Reason | The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample. |
| Root cause | Other |
| Action | Recall letters dated 6/7/05 were sent to all customers. Distributors were requested to send a copy of the notification to all customers of test strips used with the product. Users are instructed to never operate the meter without the optics cover in place, and this information will be included in test strip boxes. |
| Quantity | 2490 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040796 | ACCU-CHEK GO SYSTEM Roche Diagnostics Corp., Apr 22, 2004 |