The Recall Desk

FDA (Devices) recall action 82184

Randox Laboratories Ltd. recalled 3 products on 2019-04-17

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
2019-04-17
Critical
0
Units
74

Why these products were recalled

The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

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)··2019-04-17

    Randox Liquid Immunoassay Premium Controls Recalled for Incorrect Target Value

    Randox Laboratories is recalling Liquid Immunoassay Premium Controls because the target value for uptake is incorrect on the value sheet.

    Product
    Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
    Category
    Distribution
    2 states
  • LowFDA (Devices)··2019-04-17

    Randox Immunoassay Premium Controls Recalled for Incorrect Analyzer Target Values

    Randox Laboratories is recalling 58 units of Immunoassay Premium Controls due to an incorrect target value listed on the analyzer value sheet.

    Product
    Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
    Category
    Distribution
    2 states
  • LowFDA (Devices)··2019-04-17

    Randox Immunoassay Controls Recalled for Incorrect Analyzer Target Value

    Randox Laboratories is recalling Immunoassay Premium Plus Controls due to an incorrect target value listed on the analyzer value sheet.

    Product
    Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
    Category
    Distribution
    2 states