Z-0513-06

ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of...

Name: Z-0513-06 ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of...
Creator: Abbott Laboratories MPG
Published: 2005-12-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-12-21 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories MPG began a recall of ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott... on 2005-12-21. The reason FDA records is "There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0513-06
Status: Terminated
Initiated: 2005-12-21
Posted: 2006-02-14
Terminated: 2006-07-31
Recalling firm: Abbott Medical
Product: ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Abbott sent recall letters dated 12/20/05 to the laboratory accounts via Federal Express Priority on 12/21/05. The accounts were informed of the increase in customer complaints for failure to calibrate or inability to generate patient result errors for the Troponin-I Reagent lot, and were requested to discontinue use and destroy any of the affected lot found in inventory for replacement.
Quantity in commerce: 181 kits
Distribution: Nationwide and internationally to Canada, Australia, Germany and Taiwan
Product codes and lots: list 2K41-20, lot 95567G005, exp 6-30-2006

Product code MMI

K041192Class IIArchitect Stat Troponin-I ImmunoassayFisher Diagnostics / cleared 2004-08-12

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)