FDAAugust 9, 2019device

Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferri...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05055273204032

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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