The Recall Desk

FDA (Devices) recall action 78613

Beckman Coulter Inc. recalled 3 products on 2018-01-10

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2018-01-10
Critical
0
Units
232

Why these products were recalled

Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

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

1–3 of 3

  • LowFDA (Devices)··2018-01-10

    Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk

    Beckman Coulter is recalling Access 2 Immunoassay Systems due to a potential for minor skin burns if the tool contacts the reagent storage interface board during pipettor alignment.

    Product
    Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-01-10

    Beckman Coulter Recalls UniCel DxC 600i Systems Due to Burn Risk

    Beckman Coulter is recalling two UniCel DxC 600i SYNCHRON Access Clinical Systems because a tool may contact a board and cause minor skin burns during alignment.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-01-10

    Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk

    Beckman Coulter is recalling three Access 2 Immunoassay Systems due to a potential risk of minor skin burns during pipettor alignment.

    Product
    Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Distribution
    1 state