Z-0992-2024 Class II Ongoing
FDA device recall Z-0992-2024 was initiated by Randox Laboratories Ltd. on November 29, 2023 and is designated Class II. 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 or… The recall status is ongoing. Affected quantity: 3,053 kits (2 US, 3,051 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- November 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,053 kits (2 US, 3,051 OUS)
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.
Distribution Pattern
US Nationwide distribution in the states of SC and OK.
Code Information
Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;