Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
FDA device recall Z-0716-03 · posted 2003-04-09 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
- Action taken
- Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFR
- Distribution
- United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Norway,
- Date initiated
- 2003-02-12
- Date posted
- 2003-04-09
- Date terminated
- 2003-09-15
- 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 ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS (K982089) | Boehringer Mannheim Corp. | 1998-09-03 |