Recall Z-0274-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
| Date | Dec 25, 2003 (initiated Oct 29, 2003) |
| Status | Terminated |
| Reason | Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System. |
| Root cause | Other |
| Action | All current US AxSYM System consignees will receive the Device Correction letter via direct mailing. A 100% effectiveness check will be performed against AxSYM consignees not responding, via Customer Reply Form. An electronic copy of the Device Correction letter and communication package will be provided to all Abbott Affilities worldwide for communicating with their customers. |
| Quantity | 17,850 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974651 | ABBOTT AXSYM SYSTEM Abbott Laboratories, Feb 12, 1998 |