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Roche Diagnostics Operations, Inc. recalls Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial inf
Recalled May 26, 2021 · FDA recall Z-1596-2021 · Roche Diagnostics Operations
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. · FDA Class II
Units
726 kits
Sold at
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.
Description
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.
Product
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →