Cardiac troponin test reagent recalled for potential false results
Beckman Coulter recalls 2.1 million units of Access hsTnI reagent worldwide due to contamination causing falsely elevated troponin results in patient samples.
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: This is an FDA Class II recall of a diagnostic reagent that can produce inaccurate test results. While no illnesses or injuries have been reported, the hazard creates risk of patient harm through unnecessary cardiac procedures. This meets the criterion for Score 3 (High): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling approximately 2.1 million units of its Access hsTnI reagent, distributed worldwide. The reagent is used to measure cardiac troponin I (cTnI) levels in blood samples to diagnose heart problems.
The reason for the recall is that samples with very high troponin antigen levels (above 55,000 pg/mL) can contaminate the analyzer's probe and cause inter-assay carryover due to insufficient washing. This contamination can cause the analyzer to produce falsely elevated cTnI results in subsequent patient samples.
Falsely elevated troponin results can impact patient care if the results are near the medical decision points used for diagnosing heart attacks, potentially leading to unnecessary coronary imaging or diagnostic catheterization procedures. The affected reagent is identified by UDI/DI 15099590693183, and all lots are included in this recall.
The recalled product
- Product
- Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 2,109,804
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 (2)
- UDI/DI 15099590693183
- All Lots
Distribution
Distribution scope not specified by the agency.
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