Recall Z-0627-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Health Products, Inc.
AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064
| Date | Mar 6, 2003 (initiated Dec 13, 2002) |
| Status | Terminated |
| Reason | Results lower than package insert ranges |
| Root cause | Other |
| Action | Device Recall Letters were mailed to all Abbott customers World Wide on 12/11/02. The letter instructed to check their inventory for the recalled product, discontinue use and destroy it according to their laboratory procedures. If the product was forwarded to another laboratory, please provide them with a copy of the letter. |
| Quantity | 826 kits |
| Distribution | Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.