Roche Diagnostics Operations, Inc. Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
UDI: 04015630939381
Products Sold
UDI: 04015630939381
Roche Diagnostics Operations, Inc. is recalling Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the di due to Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 04/07/2021, Roche issued Urgent Medical Device Correction via fax notifying customers that 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 was measured immediately before the Troponin I analyte on the same module, a decreased recovery of Troponin I was observed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026