Z-0010-06

ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry...

Name: Z-0010-06 ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry...
Creator: Abbott Laboratories, Inc
Published: 2005-09-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-09-14 / Terminated / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry... on 2005-09-14. The reason FDA records is "Software deficiency causing potential shift in absorbance readings for test results". 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-0010-06
Status: Terminated
Initiated: 2005-09-14
Posted: 2005-10-06
Terminated: 2007-09-25
Recalling firm: Abbott Medical
Product: ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software deficiency causing potential shift in absorbance readings for test results.
Root cause tag: software
FDA root cause: Other
Action: Firm sent device correction letter to consignees on 9/14/2005.
Quantity in commerce: 1,107 units
Distribution: Nationwide and 21 foreign countries. Foreign countries: Mexico, Guatemala, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Puerto Rico, Jamaica, San Salvador, Canada, Germany, Singapore, China, Thailand, Australia, New Zealand, Panama, and Grand Cayman
Product codes and lots: All serial numbers, List number 1G06-01

Product code JJE

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)