Recall Z-0172-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
| Date | Jul 20, 2004 (initiated May 8, 2002) |
| Status | Terminated |
| Reason | If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open. |
| Root cause | Other |
| Action | Firm sent technical service bulletins with corrective instructions to consignees with all existing ARCHITECT i 2000 processing modules in February 2003. |
| Quantity | 1,167 units worldwide |
| Distribution | States of Virginia, Illinois, New York, Texas, Oklahoma, Pennsylvania, ILlinois, Michigan, California, New Hampshire, Ohio, Florida, Maryland, Nevada, Georgia, Minnesota, Colorado, Arizona, Missouri, Louisiana, Oregon, Wisconsin, Hawaii, Connecticut, New Hampshire, Massachusetts, Washington, South |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983212 | ABBOTT ARCHITECT TESTOSTERONE Abbott Laboratories, Nov 18, 1998 |