Recall Z-0952-2007 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, Irving, TX.
| Date | Jun 19, 2007 (initiated Apr 30, 2007) |
| Status | Terminated |
| Reason | One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chem |
| Root cause | Other |
| Action | Notification letters sent to consignees on 04/30/07. Consignees provided with work around instructions for the software glitches and asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter. This is the short term fix pending software updates, validation,and full root cause determination. |
| Quantity | 1,079 units. |
| Distribution | Worldwide distribution, including: USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, El Salvador, Germany, Guetamala, Honduras, Hong Kong, Jamaica, Japan, Korea, Mexico, New Zealand, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |