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FDAMay 22, 2018device

Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

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

The hazard

The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

Recall history

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

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