Reported Feb 14, 2024 · Ongoing

RX Series Copper (Cu) Assay Ref. Number CU2340

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

Is this the product you have?

  • RX Series Copper (Cu) Assay Ref. Number CU2340
Lot codes and dates
  • Catalogue Number/GTINCU2340 05055273201949
  • Lot/batch
    • 592278
    • 610661
    • 610669
    • 629021
    • 647201
    • 657944
Amount recalled
3,053 kits (2 US, 3,051 OUS)

Where it was sold

Why it was recalled

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

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, 6:53 PM UTC

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