Class II
Medical Device Recall: Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Randox Laboratories Ltd. · November 20, 2023
Reason for Recall
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
Distribution
US Nationwide including Puerto Rico.
States Affected
NATIONWIDE
Quantity Affected
108 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0753-2024
Status: ongoing
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