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.
This recall has been terminated (originally issued June 19, 2007).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- April 30, 2007
- Posted
- June 19, 2007
- Terminated
- March 19, 2008
- Recall Number
- Z-0952-2007
- Quantity
- 1,079 units.
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
All serial numbers.
Root 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.