The Recall Desk

FDA (Devices) recall action 84832

Beckman Coulter Inc recalled 5 products on 2020-03-11

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2020-03-11
Critical
0
Units
62,771

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2020-03-11

    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.

    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)
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2020-03-11

    Beckman Coulter Recalls Triglycerides Reagent Due to Acetaminophen Interference

    Beckman Coulter is recalling Triglycerides Reagent because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
    Category
    Distribution
    48 states
  • HighFDA (Devices)··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.

    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)
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2020-03-11

    Beckman Coulter Uric Acid Reagent Recalled for Acetaminophen Interference

    Beckman Coulter is recalling Uric Acid Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
    Category
    Distribution
    48 states