Z-0953-2007

ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number 3L77-01; Affected software: v2.10...

Name: Z-0953-2007 ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number 3L77-01; Affected software: v2.10...
Creator: Abbott Laboratories, Inc
Published: 2007-04-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-04-30 / Terminated / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and... on 2007-04-30. The reason FDA records is "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...". 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-0953-2007
Status: Terminated
Initiated: 2007-04-30
Posted: 2007-06-19
Terminated: 2008-03-19
Recalling firm: Abbott Medical
Product: ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number 3L77-01; 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 23 units.
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.
Product codes and lots: All serial numbers.

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)