RX Series Copper (Cu) Assay Ref. Number CU2340
Reported: February 14, 2024 Initiated: November 29, 2023 #Z-0992-2024
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.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 3,053 kits (2 US, 3,051 OUS)
- Distribution
- US Nationwide distribution in the states of SC and OK.
- Location
- Crumlin (North)
Frequently Asked Questions
What product was recalled? ▼
RX Series Copper (Cu) Assay Ref. Number CU2340. Recalled by Randox Laboratories Ltd.. Units affected: 3,053 kits (2 US, 3,051 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-0992-2024.
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