Randox recalls SP Control 1 (Cat. PS2682) due to potential delays in Free Kappa Light Chains test results. This affects all lots and may impact 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 is recalling its SP Control 1 test kit because Free Kappa light chains increase over time, which could delay accurate test results for conditions like Multiple Myeloma. This means lab tests using this product might not show the correct results, potentially affecting diagnosis.
Free Kappa light chains naturally increase over the product's shelf life. This can cause lab tests to show delayed results for Free Kappa Light Chains, which are used to help diagnose conditions like Multiple Myeloma and monoclonal gammopathy of undetermined significance.
Lab technicians and healthcare providers who use Randox SP Control 1 for testing. Those most at risk are patients needing accurate diagnosis of monoclonal gammopathy or Multiple Myeloma.
Check for the product name 'Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1)' with catalog number PS2682. All lots are affected.
Identify if you have Randox SP Control 1 with catalog number PS2682.
Free Kappa light chains increase over time, which may delay accurate test results for conditions like Multiple Myeloma and monoclonal gammopathy of undetermined significance.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
The product is safe for use but may cause delayed test results if used beyond the shelf life.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2278-2018 — Randox Randox Hello, I own a Randox that is covered by recall Z-2278-2018 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.
