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Recall Observatory FDA recall evidence

Device product

Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

Z-1595-2021

April 07, 2021

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 87705
Status
Ongoing
Classification
Class II
Quantity
10, 489 kits
Official record key
device-enforcement:Z-1595-2021

Official wording

Reason: 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.

Code information: UDI: 04015630939381

Distribution pattern: US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, ID, IL, IN,KS, KY, MD, ME, MO, NC, NE, NJ, NM, NY, OH, OK, SC, SD, TN, TX, VA, WA, WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.