Randox recalls SP Control 3 (Cat. PS2684) due to potential delays in Free Kappa Light Chain results affecting monoclonal gammopathy diagnosis. All lots are affected.
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.
Randox is recalling its SP Control 3 test kit because Free Kappa light chains increase over time, which could delay accurate results for diagnosing certain blood conditions. This affects lab tests used to detect monoclonal gammopathy and Multiple Myeloma.
Free Kappa light chains naturally increase over the product's shelf life. This can cause delays in reporting accurate results for Free Kappa Light Chain tests, which are used to help diagnose monoclonal gammopathy and Multiple Myeloma.
Lab users who test with SP Control 3 (Cat. PS2684) may be affected. Those using the product for diagnosing monoclonal gammopathy or Multiple Myeloma are most at risk.
Check for the product name 'Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3)' with catalog number PS2684. All lots are affected.
Verify the catalog number is PS2684 and the product name matches Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3).
Free Kappa light chains increase over the product's shelf life, which may delay accurate results for diagnosing monoclonal gammopathy and Multiple Myeloma.
The recall record does not specify a remedy.
The product may cause delays in reporting Free Kappa Light Chain results, which are used to help diagnose certain blood conditions.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2280-2018 — Randox Randox Hello, I own a Randox that is covered by recall Z-2280-2018 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
