Z-0870-03

Elecsys Troponin T; catalog number 2017644

Name: Z-0870-03 Elecsys Troponin T; catalog number 2017644
Creator: Roche Diagnostics Corp.
Published: 2003-04-25
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-04-25 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Elecsys Troponin T; catalog number 2017644 on 2003-04-25. The reason FDA records is "Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0870-03
Status: Terminated
Initiated: 2003-04-25
Posted: 2003-05-29
Terminated: 2003-06-19
Recalling firm: Roche Diagnostics GmbH
Product: Elecsys Troponin T; catalog number 2017644
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
FDA root cause: Other
Action: An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL.
Distribution: United States
Product codes and lots: All lots.

Product code MMI

K984105Class IIElecsys Troponin T Stat TestBoehringer Mannheim Corp. / cleared 1998-12-08

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)