Randox Laboratories Ltd. recalls Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement…

Recall date

July 19, 2023

Source

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

Recall number

Z-2448-2023

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

CA, FL, IL, ME, MI, NC, OH, PA,NJ,

Why it was recalled

As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

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

What was recalled

Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691