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Terminated

Elecsys Troponin T; catalog number 2017644

FDA Recall Z-0870-03 · Posted 2003-05-29

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeMMI
Date Initiated2003-04-25
Date Terminated2003-06-19

Reason for Recall

Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.

Firm 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.

Root Cause

Other

Distribution Pattern

United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984105ELECSYS TROPONIN T STAT TESTBoehringer Mannheim Corp. · 1998-12-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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