Z-2231-2008

ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected...

Name: Z-2231-2008 ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected...
Creator: Abbott Laboratories, Inc
Published: 2008-05-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-05-23 / Terminated / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of 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... on 2008-05-23. The reason FDA records is "Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2231-2008
Status: Terminated
Initiated: 2008-05-23
Posted: 2008-09-11
Terminated: 2010-04-26
Recalling firm: Abbott Medical
Product: 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.
Product code: CGZ Electrode, Ion-Specific, Chloride
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 2,378 units worldwide (431 in the USA; plus 1,947 International)
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.
Product codes and lots: 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

Product code CGZ

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)