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Open, Classified

Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

FDA Recall Z-0753-2024 · Posted 2024-01-18

Recalling FirmRandox Laboratories Ltd.
Recall StatusOpen, Classified
Product CodeJIX
Date Initiated2023-11-20
Product Quantity108 kits

Reason for Recall

Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

Firm Action

Randox issued Urgent Medical Device Correction letter on 11/20/23 to the distribution center within the USA. The US distributor contacted the customer direct via email. Letter states reason for recall, health risk and action to take: Review your calibrator inventory of this lot and assess your laboratories needs for reimbursement for discarded inventory. " 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. If you have any questions or concerns please contact Randox Technical Services.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide including 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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