The Recall Desk

FDA (Devices) recall action 85289

Beckman Coulter Inc. recalled 2 products on 2020-04-29

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2020-04-29
Critical
0
Units
9,561

Why these products were recalled

Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.

Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.

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

1–2 of 2

  • ModerateFDA (Devices)··2020-04-29

    Beckman Coulter Recalls Synchron Opiate 2000 ng Reagent Due to Cross-Reactivity

    Beckman Coulter is recalling Synchron Opiate 2000 ng Reagent because cross-reactivity testing may not meet instructions for use, potentially causing false positive or negative urine test results.

    Product
    Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2020-04-29

    Beckman Coulter Recalls Opiate 300 Ng Reagent Due to Cross-Reactivity Issues

    Beckman Coulter is recalling Opiate 300 Ng Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative urine test results.

    Product
    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
    Category
    Distribution
    34 states