Drug recall
Direct Bilirubin Reagents (DBIL 2 x 200) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300…
FDA recall event 84832 · Class II · Beckman Coulter Inc
Key facts
| Event ID | 84832 |
|---|---|
| Recall numbers | Z-1422-2020, Z-1423-2020, Z-1424-2020, Z-1425-2020, Z-1426-2020 |
| Recalling firm | Beckman Coulter Inc |
| Product type | Devices |
| Products | 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…, Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733, 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…, Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228, Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Aug 15, 2019 |
| Report date | Mar 11, 2020 |
| Termination date | Feb 28, 2024 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 2050010 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: