ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.
FDA device recall Z-1370-05 · posted 2005-08-13 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 2490
- Distribution
- Nationwide.
- Date initiated
- 2005-06-07
- Date posted
- 2005-08-13
- Date terminated
- 2007-07-02
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK GO SYSTEM (K040796) | Roche Diagnostics Corp. | 2004-04-22 |