Reported Jan 24, 2024 · Ongoing

Calibration Serum Level 3 CAL2351

Randox Laboratories Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A

Is this the product you have?

  • Calibration Serum Level 3 CAL2351
Lot codes and dates
  • GTIN05055273200966
  • Lot Numbers
    • 1214UE
    • 1249UE
    • 1260UE
    • 1262UE
    • 1268UE
    • 1297UE
    • 1298UE
    • 1315UE
Amount recalled
269 kits

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.