Recall Z-1316-2010 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. The Abbott ARCHITECT System is designed to perform automated: Chemistry tests utilizing photometry and potentiometric technology, and immunoassay tests utilizi
| Date | Apr 9, 2010 (initiated Sep 11, 2009) |
| Status | Terminated |
| Reason | ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters. |
| Root cause | Software design |
| Action | Technical Service Bulletins dated September 11, 2009 were issued to affected consignees. The correction was issued via the Technical Service Bulletins (TSB) to provide a software patch to re-establish the correct parameters on the LLS board. Direct questions to Abbott Laboratories, Inc. by calling 1-972-518-6000. |
| Quantity | 11 in the USA; 104 worldwide |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983212 | ABBOTT ARCHITECT TESTOSTERONE Abbott Laboratories, Nov 18, 1998 |