FDA Enforcement
Class II
Ongoing
RX Series Copper (Cu) Assay Ref. Number CU2340
Recall: Z-0992-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0992-2024
- Event ID
- 93775
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Randox Laboratories Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- November 29, 2023
- Classification Date
- February 6, 2024
- Address
- 55 Diamond Road, Crumlin (North), N/A, Ireland
Description
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.
Code Info
Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;
Distribution
US Nationwide distribution in the states of SC and OK.
Quantity
3,053 kits (2 US, 3,051 OUS)