FDAApril 7, 2021device

Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

What to do

FDA enforcement status: Ongoing

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

0401563093937405094810160

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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