Z-1133-03

ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas

Name: Z-1133-03 ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas
Creator: Abbott Laboratories, Inc
Published: 2001-12-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2001-12-10 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas on 2001-12-10. The reason FDA records is "Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1133-03
Status: Terminated
Initiated: 2001-12-10
Posted: 2003-08-13
Terminated: 2003-08-12
Recalling firm: Abbott Medical
Product: ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.
FDA root cause: Other
Action: Technical Service Bulletin 114-041 was sent to the Abbott Laboratories Field Service Organization with instructions to correct all ARCHITECT i 2000 systems worldwide.
Quantity in commerce: 787
Distribution: Nationwide and to the following foreign countries: Canada, Mexico, Venezuela, Chile, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand.
Product codes and lots: All units

Product code JJE

K983212Class IAbbott Architect TestosteroneAbbott Laboratories / cleared 1998-11-18

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)