The Recall Desk

FDA (Devices) recall action 83791

Randox Laboratories Ltd. recalled 2 products on 2019-11-13

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
2019-11-13
Critical
0
Units
117

Why these products were recalled

The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

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)··2019-11-13

    Randox Rheumatoid Factor Standard Recalled for Value Adjustment

    Randox Laboratories is recalling 17 Rheumatoid Factor Standard kits because assigned values over-recovered against reference material. The values have been adjusted to align with the reference standard.

    Product
    Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human…
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2019-11-13

    Randox Liquid Protein Calibrators Recalled for Rheumatoid Factor Value Adjustment

    Randox Laboratories is recalling 100 kits of Liquid Protein Calibrators because the assigned value for Rheumatoid Factor over-recovered against the reference material. The calibrator values have been adjusted to re-align to the reference material.

    Product
    Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM…
    Category
    Distribution
    5 states