Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
FDA device recall Z-1303-04 · posted 2004-07-31 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Coating defect may result is falsely decreased patient and/or control results.
- Action taken
- Recall letters dated 7/14/04 were sent to each customer asking that use of these lots be stopped immediately. Testing labs were asked to notify the attending physician for any patients tested with these test strips.
- Root cause
- Other
- Status
- Terminated
- Product code
- CIT
- Quantity affected
- 197 boxes
- Distribution
- United States.
- Date initiated
- 2004-07-14
- Date posted
- 2004-07-31
- Date terminated
- 2004-10-14
- 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 |
|---|---|---|
| REFLOTRON(R) ALT (GPT) (K864082) | Boehringer Mannheim Corp. | 1986-12-04 |