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FDAFDA · Food and drugs·Recall number Z-0992-2024

RX Series Copper (Cu) Assay Ref. Number CU2340

Published February 14, 2024 · Recall initiated: November 29, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Randox Laboratories Ltd.
Distributor
US Nationwide distribution in the states of SC and OK.
Lot
Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;
Risk classification
Class II
Area (FDA)
device
Country
Ireland

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