Z-0782-04

AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

Name: Z-0782-04 AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2004-03-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-03-26 / Terminated

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 on 2004-03-26. The reason FDA records is "An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0782-04
Status: Terminated
Initiated: 2004-03-26
Posted: 2004-07-20
Terminated: 2004-10-14
Recalling firm: Abbott Medical
Product: AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction.
FDA root cause: Other
Action: Recalled by telephone calls on 3/26/04 and a follow-up letter dated 3/25/04. The accounts were informed of the elevated patient results for the Troponin-I Reagent lots, and were requested to discontinue use and destroy any of the four affected lots found in inventory.
Quantity in commerce: 7,394 kits
Distribution: Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, Taiwan, Australia, New Zealand, Thailand, China and Korea.
Product codes and lots: lot numbers 10264M300, 10264M301, 10265M300, and 10265M301

Product code MMI

K974103Class IIAbbott Axsym Troponin-IAbbott Laboratories / cleared 1997-11-25

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)