FDANovember 22, 2022device

Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683

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

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

randox laboratoriesrandox

UPCs

05055273204902

Recall history

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

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Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683 — Recall Details · AllClear