RX Series Copper recall
RX Series Copper (Cu) Assay Ref. Number CU2340
Why was RX Series Copper 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;
- Product
- RX Series Copper (Cu) Assay Ref. Number CU2340
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 3,053 kits (2 US, 3,051 OUS)
- Distribution
- US Nationwide distribution in the states of SC and OK.
- Recall date
- February 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)