medical Class II Updated 2018-07-04

Randox Laboratories Ltd. recalls Randox Liquid Assayed Specific Protein Control - Level 1 (SP

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, IN, KS, ME, WV
Lot/Code Info: All lots.
View official government recall

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