Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside
FDA device recall Z-0573-06 · posted 2006-02-28 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings..
- Action taken
- Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFR
- Distribution
- Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru,
- Date initiated
- 2006-02-10
- Date posted
- 2006-02-28
- Date terminated
- 2007-02-08
- 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 COMFORT CURVE TEST STRIP (K010362) | Roche Diagnostics Corp. | 2001-03-07 |
| ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS (K982089) | Boehringer Mannheim Corp. | 1998-09-03 |