Class II

Medical Device Recall: Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

Randox Laboratories Ltd. · March 1, 2024

Reason for Recall

The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

Distribution

Domestic: CA, FL, IL, ME, NJ, OH, & OR.

States Affected

CA, FL, IL, ME, NJ, OH, OR

Quantity Affected

1,764 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1328-2024

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.