Recall Z-0146-2008 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratories, Irving, TX.
| Date | Nov 7, 2007 (initiated Sep 5, 2007) |
| Status | Terminated |
| Reason | Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler. |
| Root cause | Software change control |
| Action | Notification letters sent to consignees on 09/17/07. Consignees informed of the software defect and the conditions that would cause the software error to occur. Consignees told they would be contacted by an Abbott Field Service Rep who would install ARCHITECT System Software v3.11 and were asked to respond via fax using Customer Reply form acknowledging receipt and understanding of correction letter. Firm recalling to hospital/user level. |
| Quantity | 2070 units. |
| Distribution | Worldwide Distribution: USA (including Puerto Rico), Argentina, Australia, Bahamas, Bermuda, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Singapore, Thailand, Trinidad and Tobago |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |