ACCU-CHEK Instant Care Kit; Catalog number 91490.
FDA device recall Z-0979-05 · posted 2005-07-13 · 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 while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood.
- 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
- CGA
- Distribution
- Nationwide.
- Date initiated
- 2005-05-18
- Date posted
- 2005-07-13
- Date terminated
- 2006-02-26
- 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 ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS (K952875) | Boehringer Mannheim Corp. | 1995-11-21 |