The Recall Desk

FDA (Devices) recall action 91225

Randox Laboratories Ltd. recalled 3 products on 2023-01-11

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
2023-01-11
Critical
0
Units
310

Why these products were recalled

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

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

  • ModerateFDA (Devices)··2023-01-11

    Quality Control Material Potency Decline Causes Out-of-Range Laboratory Results

    Randox Laboratories recalls a quality control product (PS2682) because Rheumatoid Factor concentration has declined, causing out-of-range quality control results and delayed laboratory test reporting.

    Product
    Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2023-01-11

    Laboratory quality control material with degraded potency affecting diagnostic verification

    Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.

    Product
    Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2023-01-11

    Randox Protein Control Material Concentration Decreased, Affecting Quality Control

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 3 (catalog PS2684) because the concentration of rheumatoid factor has decreased, causing quality control systems to run outside acceptable ranges and delaying test result reporting.

    Product
    Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
    Category
    Distribution
    9 states