Agency classClass IIOur severity:High FDA (Devices)·Z-1595-2021·Announced 2021-05-26

Roche Recalls Troponin I STAT Immunoassay Kits Due to False Negative Risk

Roche Diagnostics is recalling 10,489 Troponin I STAT Immunoassay kits because they may produce false negative results when run after proBNP II tests on specific modules.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for diagnosing myocardial infarction that may produce false negative results. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are cited in the source text.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 10,489 kits of the Elecsys Troponin I STAT Immunoassay (Catalog# 05094798160). The product is intended to aid in the diagnosis of myocardial infarction. The recall is due to a potential issue where the test may produce sporadic false negative results.

Roche confirmed that an issue occurs when the Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT tests are run on cobas e 601 and 602 modules. Specifically, 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. This sequence of testing can lead to inaccurate results.

The affected kits were distributed nationwide in the United States, including 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, and WY. Healthcare facilities and laboratories should stop using the affected kits and contact Roche Diagnostics for further instructions on how to manage the recall.

The recalled product

Product: Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: false-negative-result
diagnostic-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI: 04015630939381

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Roche Diagnostics Operations, Inc.

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Same hazard · false negative result