Recall Z-1133-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas
| Date | Aug 13, 2003 (initiated Dec 10, 2001) |
| Status | Terminated |
| Reason | Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier. |
| Root cause | Other |
| Action | Technical Service Bulletin 114-041 was sent to the Abbott Laboratories Field Service Organization with instructions to correct all ARCHITECT i 2000 systems worldwide. |
| Quantity | 787 |
| Distribution | Nationwide and to the following foreign countries: Canada, Mexico, Venezuela, Chile, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983212 | ABBOTT ARCHITECT TESTOSTERONE Abbott Laboratories, Nov 18, 1998 |