Randox recalls SP Control 2 (Cat. PS2683) due to Free Kappa light chains increasing over shelf life, potentially delaying diagnosis of monoclonal gammopathy and multiple myeloma.
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 recalls its SP Control 2 protein test kit because Free Kappa light chains increase over time, which could delay accurate diagnosis of certain blood conditions. This affects lab tests used to detect monoclonal gammopathy and multiple myeloma.
Free Kappa light chains naturally increase in the test solution over time. This can cause inaccurate results when used to measure ratios with free lambda chains, potentially delaying diagnosis of blood conditions like multiple myeloma.
Lab technicians and healthcare providers who use Randox SP Control 2 for blood tests may be affected. Those testing for monoclonal gammopathy or multiple myeloma are at slightly higher risk.
Check for the product name 'Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2)' with catalog number PS2683. All lots of this product are affected.
Identify the product name and catalog number to confirm if it's affected.
Free Kappa light chains increase over the shelf life of the product, which may delay accurate diagnosis of monoclonal gammopathy and multiple myeloma.
The recall record does not mention a remedy or fix.
Look for the product name 'Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2)' with catalog number PS2683. All lots are affected.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2279-2018 — Randox Randox Hello, I own a Randox that is covered by recall Z-2279-2018 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.
