Lower riskMedical device recall · FDA · Published May 22, 2018
Randox SP Control 2 may delay Free Kappa Light Chain results
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. Read more at govinfonow.com/recall/71001-randox-sp-control-2-may-delay-free-kappa-light-chain.
“Randox SP Control 2 may delay Free Kappa Light Chain results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/71001-randox-sp-control-2-may-delay-free-kappa-light-chain. Based on FDA recall #Z-2279-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2279-2018%22&limit=1).
The FDA announced on May 22, 2018, that Randox Laboratories Ltd. is recalling Randox Liquid Assayed Specific Protein Control - Level 2 (Cat. no. PS2683) because Free Kappa light chains increase over the product's shelf life. This defect may lead to a delay in reporting results used to aid in the diagnosis of monoclonal gammopathy of undetermined significance and Multiple Myeloma.
How to tell if you have it
Brand: Randox
Product: Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2)
Catalog number: PS2683
Lots: All lots
The hazard
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.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Other recent recalls include a Cystatin C Reagent recall for missing FDA 510(k) status (June 7, 2024), an Evidence MultiSTAT Software recall for light leak risk (April 5, 2024), and a Clinical Chemistry Calibration Serum recall for inorganic phosphate bias (March 5, 2024). Other recent recalls of similar products include Stago STA Liatest Free Protein S for risk of inaccurate test results (Feb. 4, 2026).
How to tell if you have this one
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.
Brand
Randox
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
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, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Italy, Jordan, Kenya, Saudi Arabia, Korea, Kuwait, Latvia, Lebanon, Peru, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Morocco, Myanmar, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Oman, Thailand, Netherlands, Turkey, United Arab Emirates, United Kingdom, Ukraine, Vietnam, and Zimbabwe.
Recall number
Product, codes & lots
Quantity
Z-2278-2018
Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682; All lots.
—
Z-2279-2018
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683; All lots.
—
Z-2280-2018
Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684; All lots.
—
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product name and catalog number to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 5 states and Puerto Rico, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Indiana, Kansas, Maine, Puerto Rico, West Virginia.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2279-2018 (May 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2279-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.