ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, Irving, TX.
FDA Recall Z-0950-2007 · Posted 2007-06-19
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Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2007-04-30
Date Terminated2008-03-19
Product Quantity170 units.
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
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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