Recall Z-0743-2007 ยท JIX Calibrator, Multi-Analyte Mixture
Mega Diagnostics
Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials
| Date | Apr 14, 2007 (initiated Sep 20, 2006) |
| Status | Terminated |
| Reason | Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product. |
| Root cause | Other |
| Action | The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product |
| Quantity | 12 Units |
| Distribution | Country of Indonesia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972333 | AMMONIA/IRON STANDARD KIT Verichem Laboratories, Inc., Jul 23, 1997 |