Class II

Medical Device Recall: Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

Randox Laboratories Ltd. · March 5, 2024

Reason for Recall

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

Distribution

Domestic: Nationwide Distribution.

States Affected

NATIONWIDE

Quantity Affected

80,366 units (US: 242 units; OUS: 80,094 units)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1759-2024

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.

Randox Laboratories Ltd. Medical Device Recall: Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests. | SafeCheck