Z-0172-04

ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas

Name: Z-0172-04 ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
Creator: Abbott Laboratories, Inc
Published: 2002-05-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2002-05-08 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas on 2002-05-08. The reason FDA records is "If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0172-04
Status: Terminated
Initiated: 2002-05-08
Posted: 2004-07-20
Terminated: 2003-11-26
Recalling firm: Abbott Medical
Product: ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.
FDA root cause: Other
Action: Firm sent technical service bulletins with corrective instructions to consignees with all existing ARCHITECT i 2000 processing modules in February 2003.
Quantity in commerce: 1,167 units worldwide
Distribution: States of Virginia, Illinois, New York, Texas, Oklahoma, Pennsylvania, ILlinois, Michigan, California, New Hampshire, Ohio, Florida, Maryland, Nevada, Georgia, Minnesota, Colorado, Arizona, Missouri, Louisiana, Oregon, Wisconsin, Hawaii, Connecticut, New Hampshire, Massachusetts, Washington, South Carolina, Mississippi, Alabama, and Tennessee, and the following foreign countries: Austria, Denmark, Germany, Italy, Poland, South Africa, Sweden, England, Colombia, Australia, Japan, New Zealand, Belgium, Finland, Greece, Netherlands, Portugal, Romania, Turkey, Canada, Mexico, Hong Kong, Korea, Taiwan, Czech Republic, France, Israel, Norway, Saudi Arabia, Spain, United Arab Emirates, Brazil, Venezuela, India, Malaysia, and Thailand.
Product codes and lots: All Serial numbers

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)