Official recall record
RX Series Copper (Cu) Assay Ref. Number CU2340
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-29
- Country of alert
- Ireland
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05055273201949
- Brand on record
- Randox Laboratories Ltd.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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All 7 official recall notices naming Randox Laboratories Ltd. on this site →
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