Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Reported: May 26, 2021 Initiated: April 7, 2021 #Z-1595-2021
Product Description
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Reason for Recall
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 10, 489 kits
- Distribution
- 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.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 10, 489 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 26, 2021. Severity: Moderate. Recall number: Z-1595-2021.
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