ACCU-CHEK Inform meter; catalog No. 3035123.
FDA device recall Z-1060-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
- Action taken
- A recall notice dated 6/30/04 was sent to each customer instructing them on proper cleaning methods, asking them to inspect their units for damage, and providing warning stickers for attachment to the base units.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Distribution
- Nationwide.
- Date initiated
- 2004-06-30
- Date posted
- 2004-07-20
- Date terminated
- 2005-10-03
- 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 |
|---|---|---|
| MODIFICATION TO ACCU-CHEK INFORM METER (K012210) | Roche Diagnostics Corp. | 2001-08-09 |
| ACCU-CHEK INFORM METER (K003846) | Roche Diagnostics Corp. | 2001-03-19 |