Randox Laboratories recalls CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cat…

Recall date

February 1, 2023

Source

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

Recall number

Z-1286-2023

FDA classification

Class II

Brand / firm

Randox Laboratories

Sold / distributed

PA, OH, WV

Why it was recalled

The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within 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

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826