Class II
Medical Device Recall: Calibration Serum Level 3 CAL2351
Randox Laboratories Ltd. · November 20, 2023
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%.
Distribution
US Nationwide and Puerto Rico.
States Affected
NATIONWIDE
Quantity Affected
269 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0752-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.