medical Class II Updated 2021-05-26

Roche Diagnostics Operations, Inc. recalls Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Produ

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 04015630939374
View official government recall

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