ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; distributed by Abbott Laboratories, Irving, TX. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
This recall has been terminated (originally issued September 11, 2008).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- May 23, 2008
- Posted
- September 11, 2008
- Terminated
- April 26, 2010
- Recall Number
- Z-2231-2008
- Quantity
- 2,378 units worldwide (431 in the USA; plus 1,947 International)
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.
Distribution
Worldwide distribution, including: USA (including Puerto Rico), Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Grand Cayman, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, UAE, United Kingdom, Uruguay, and Venezuela.
Lot / Code Info
Version 2.20, List #05F48-13, Part #7-201738-01; Version 2.20DB, List #05F48-14, Part #7-201738-02; Version 2.60, List #05F48-17, Part #7-203715-01; Version 3.10, List #05F48-18, Part #7-203715-02; Version 3.11, List #05F48-20, Part 7-203715-03; and Version 3.12, List #05F48-21
Root Cause
Software design
Action Taken
Firm notified all ARCHITECT c8000 customers with a correction letter and response form distributed on 5/23/2008. The letter provided actions the users could take until an updated software version was available. For assistance, contact Abbott at 1-877-4ABBOTT.