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Open, Classified

Calibration Serum Level 3 CAL2351

FDA Recall Z-0752-2024 · Posted 2024-01-18

Recalling FirmRandox Laboratories Ltd.
Recall StatusOpen, Classified
Product CodeJIX
Date Initiated2023-11-20
Product Quantity269 kits

Reason for Recall

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

Firm Action

Randox issued Urgent Medical Device Correction Letter via email to the US and PR Distributors on 11/20/23. Distributors contacted the customer directly. The Letter states reason for recall, health risk and action to take: Action to be taken: " Discuss the contents of this notice with your Medical Director if you have used the RX Series targets for CK Total in the aforementioned lots. " Complete and return the response form, 12187-QA to [email protected] within five working days. " Please discard all copies of the IFUs and download the latest versions from www.randox.com. If you have any questions or concerns please contact Randox Technical Services.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053153RANDOX CALIBRATION SERUMRandox Laboratories, Ltd. · 2006-01-13

Official Source

View FDA Recall →

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

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