FDA (Devices) recall action 80211
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 2 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.
Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 3 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.
Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 1 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.