Z-0512-06

Roche brand Elecsys Troponin T; catalog number 2017644

Name: Z-0512-06 Roche brand Elecsys Troponin T; catalog number 2017644
Creator: Roche Diagnostics Corp.
Published: 2006-01-31
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-01-31 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche brand Elecsys Troponin T; catalog number 2017644 on 2006-01-31. The reason FDA records is "A false negative result may be reported". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0512-06
Status: Terminated
Initiated: 2006-01-31
Posted: 2006-02-09
Terminated: 2006-04-10
Recalling firm: Roche Diagnostics GmbH
Product: Roche brand Elecsys Troponin T; catalog number 2017644.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: A false negative result may be reported.
FDA root cause: Other
Action: Recall letter dated 1/31/06 was issued to each customer instructing them to stop using, and to discard, the product.
Quantity in commerce: 3116 kits
Distribution: Nationwide.
Product codes and lots: Lot 171924-02.

Product code MMI

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)