Recall Z-0992-2024— Randox Laboratories Ltd.
Class II · Ongoing
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2023-11-29. FDA's recall record names no specific 510(k) clearance for this event. Product: RX Series Copper (Cu) Assay Ref. Number CU2340. Reason: 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..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-29
- Firm location
- Crumlin (North), Ireland
Product description
RX Series Copper (Cu) Assay Ref. Number CU2340
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.