Recall Z-0147-2008
Abbott Laboratories, Inc · initiated September 5, 2007
Product
ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; 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.
Codes / lots: All Serial Numbers--ARCHITECT cSystems using ARCHITECT System Software Versions: ---Software Version--List Number--Part Number-- 2.10-- 05F48-11-- 7-99077-01 2.11-- 05F48-12 --7-99077-02 2.12 --None --------7-99077-03 2.20 --05F48-13 ---7-201738-01 2.20DB --05F48-14 ---7-201738-02 2.30-- None --202246-01 2.60-- 05F48-17-- 7-203715-01 3.00-- 05F48-15-- 7-202246-01 3.10-- 05F48-18-- 7-203715-02
Reason for recall
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.
FDA-determined cause: Software change control
Action taken
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.
Details
- Recall number
- Z-0147-2008
- Initiated
- September 5, 2007
- Posted by FDA
- November 7, 2007
- Terminated
- October 4, 2010
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 89 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, Uruguay, and Venezuela.
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0146-2008 | ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01…Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT… | 09/05/2007Terminated |