Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials
FDA device recall Z-0743-2007 · posted 2007-04-14 · Terminated
Recall details
- Recalling firm
- Mega Diagnostics
- Reason for recall
- Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product.
- Action taken
- The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product
- Root cause
- Other
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 12 Units
- Distribution
- Country of Indonesia
- Date initiated
- 2006-09-20
- Date posted
- 2007-04-14
- Date terminated
- 2012-06-04
- Location
- Los Angeles, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMMONIA/IRON STANDARD KIT (K972333) | Verichem Laboratories, Inc. | 1997-07-23 |