Medical device recalls Moderate risk

Randox Laboratories Ltd. recalls Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays tha…

Recall date
March 1, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1328-2024
FDA classification
Class II
Brand / firm
Randox Laboratories Ltd.
Sold / distributed
Domestic: CA, FL, IL, ME, NJ, OH, & OR.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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