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.
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) 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Beckman Coulter Inc
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- High
Same hazard · test interference
See all →- HighSiemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results
FDA (Devices) · 2024-04-24
- HighFetal Membrane Rupture Test Kits Recalled for False Positive Results
FDA (Devices) · 2024-04-24
- HighAbbott Alinity i Anti-HCV Reagent Kit Recall for Falsely Elevated Test Results
FDA (Devices) · 2024-04-10
- HighHepatitis B Diagnostic Test Kits Recalled for Test Interference
FDA (Devices) · 2023-03-01
- HighFDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination
FDA (Devices) · 2022-06-15
Similar recalls
- ModerateBeckman Coulter Recalls Uric Acid Reagent Due to Drug Interference
FDA (Devices) · 2017-05-24
- HighBeckman Coulter Uric Acid Assay Recalled Due to Interference
FDA (Devices) · 2019-10-30
- ModerateBeckman Coulter Cholesterol Reagent Recalled for Potential Drug Interference
FDA (Devices) · 2017-05-24
- ModerateBeckman Coulter Recalls Triglycerides Reagent Due to Interference
FDA (Devices) · 2017-05-24
- ModerateBeckman Coulter Recalls Enzymatic Creatinine Reagent Due to Interference
FDA (Devices) · 2017-05-24
- ModerateBeckman Coulter Recalls HDL Cholesterol Reagent Due to Drug Interference
FDA (Devices) · 2017-05-24