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Open, Classified

RX Series Copper (Cu) Assay Ref. Number CU2340

FDA Recall Z-0992-2024 · Posted 2024-02-06

Recalling FirmRandox Laboratories Ltd.
Recall StatusOpen, Classified
Product CodeJKZ
Date Initiated2023-11-29
Product Quantity3,053 kits (2 US, 3,051 OUS)

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.

Firm Action

RANDOX Distributors issued Medical Device Correction Letter (REC704) on December 12, 2023 to US consignees. Letter states reason for recall, health risk and action to take: Review your instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0148) " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0148) and ensure all operators are aware of the recommendations. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide distribution in the states of SC and OK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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