Agency classClass IIOur severity:High FDA (Devices)·Z-1596-2021·Announced 2021-05-26

Roche Recalls Troponin I Immunoassay Kits Due to False Negative Risk

Roche Diagnostics is recalling 726 Elecsys Troponin I Immunoassay kits because they may produce false negative results when run immediately 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 high-risk diagnostic test for myocardial infarction where false negatives could lead to missed diagnoses, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 726 kits of the Elecsys Troponin I Immunoassay (Catalog# 05094810160). This medical device 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.

The problem occurs when the Elecsys proBNP II analyte is measured immediately before the Troponin I analyte on the same cobas e 601 or 602 module. In these specific conditions, a decreased recovery on Troponin I was observed. The affected products were distributed nationwide 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 instructions on how to return or dispose of the product. Users should verify the UDI 04015630939374 to identify affected units.

The recalled product

Product: Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: false-negative-result
mis-diagnosis
Affected units: 726

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: 04015630939374

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