medical Class II Updated 2020-03-11

Beckman Coulter Inc recalls Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300)

Recalled Product

Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)


Hazard / Issue

It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lot Numbers
View official government recall

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