The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1426-2020·Announced 2020-03-11

Beckman Coulter Total Bilirubin Reagent Recalled for Acetaminophen Interference

Beckman Coulter is recalling Total Bilirubin Reagents 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 is classified as FDA Class II, and the hazard involves a risk of harm (delayed diagnosis and treatment) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Beckman Coulter Inc is recalling 25,383 units of Total Bilirubin Reagent (TBIL 2 x 300 and TBIL 2 x 400) for in vitro diagnostic use. The affected products are identified by Reference numbers 442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), with UDI codes 15099590233075 and 15099590625597, respectively. The recall covers all lot numbers.

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 for patients.

The products were distributed to 48 U.S. states and numerous international locations, including Canada, the United Kingdom, and Australia. Healthcare providers and laboratories using these reagents should stop using the affected products and contact Beckman Coulter for further instructions.

The recalled product

Product
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge)
Manufacturer
Beckman Coulter Inc
Category
Medical Device — In Vitro Diagnostic Reagent
Hazard
Affected units
25,383

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

Distributed in 48 states:

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.

See all 5 products in this recall →

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