ACCU-CHEK Compact Meter; catalog number 3183572.
FDA device recall Z-0976-05 · posted 2005-07-12 · 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 the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip.
- Action taken
- A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Distribution
- Nationwide.
- Date initiated
- 2005-05-18
- Date posted
- 2005-07-12
- Date terminated
- 2005-12-12
- Location
- Indianapolis, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK COMPACT SYSTEM (K022171) | Roche Diagnostics Corp. | 2002-07-23 |