Beckman Coulter Recalls Triglycerides Reagent Due to Acetaminophen Interference
Beckman Coulter is recalling Triglycerides Reagent because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
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 risk-of-harm product where the hazard is a delay in diagnosis and treatment due to assay interference, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Beckman Coulter Inc is recalling Triglycerides Reagent (TG 2 x 300), REF: 445850, for in vitro diagnostic use. The recall affects all lot numbers of the product.
The recall was initiated because N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference in the assays if present in high quantities in serum due to acetaminophen overdoses. This interference could result in a delay in diagnosis and treatment.
The product was distributed in the United States and numerous international locations, including Canada, the United Kingdom, and Australia. Users should stop using the product and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
- Manufacturer
- Beckman Coulter Inc
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)
- All Lot Numbers
Distribution
Part of a larger recall action
This product is one of 5 recalled by Beckman Coulter 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.
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