Recall Z-0953-2007
Abbott Laboratories, Inc · initiated April 30, 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 and v3.00; distributed by Abbott Laboratories, Irving, TX.
Codes / lots: All serial numbers.
Reason for recall
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
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0953-2007
- Initiated
- April 30, 2007
- Posted by FDA
- June 19, 2007
- Terminated
- March 19, 2008
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 23 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, Thailand, Trinidad/Tobago, Uruguay, and Venezuela.
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0950-2007 | ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10…One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline… | 04/30/2007Terminated |
| Z-0951-2007 | ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number 3M74-01…One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline… | 04/30/2007Terminated |
| Z-0952-2007 | ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01…One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline… | 04/30/2007Terminated |