Randox Laboratories Ltd. recalls Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

Recall date

May 22, 2018

Source

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

Recall number

Z-2280-2018

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

Distributed to accounts in CA, IN, KS, ME, and WV, and PR. Foreign distribution to Australia, Bangladesh, Belarus, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Cyprus, Denmark, Dutch Caribbean, Ecuador, Egypt, El Salvador, Ethiopia, Falkland Islands, Finland, France, Georgia, Germany,…

Why it was recalled

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.

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 Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684