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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