Beckman Coulter Recalls Direct Bilirubin Reagents Due to Interference Risk
Beckman Coulter is recalling Direct Bilirubin Reagents because acetaminophen metabolites may interfere with test results, potentially delaying diagnosis and treatment.
What this means for you
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) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Beckman Coulter Inc is recalling Direct Bilirubin Reagents (DBIL 2 x 200 and DBIL 2 x 300) for in vitro diagnostic use. The recall involves 17,824 reagents distributed across the United States and numerous international locations. The affected products are identified by Reference numbers 439715 and 476856, and UDI codes 15099590575120 and 15099590625603.
The recall was initiated because N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference in these assays if present in high quantities in serum. This interference could result in a delay in diagnosis and treatment for patients. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare facilities and laboratories should stop using the affected reagents and contact Beckman Coulter for instructions on return or replacement. Consumers should not use these products for home testing, as they are for in vitro diagnostic use and require a prescription.
The recalled product
- 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)
- Manufacturer
- Beckman Coulter Inc
- Affected units
- 17,824
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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