Randox Laboratories Ltd. recalls Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical c…

Recall date

November 22, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0905-2023

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.

Why it was recalled

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

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 Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684