Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues
Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 1 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a delay in diagnostic reporting rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving potential adverse health consequences through diagnostic error.
Plain-English summary
Randox Laboratories Ltd. is recalling Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Catalog No. PS2682. The recall affects all lots of the product.
The firm confirmed that Free Kappa light chains in the product increase over its shelf life. This instability may lead to a delay in reporting Free Kappa Light Chains results. These results are used as an aid in the diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.
The product was distributed to accounts in California, Indiana, Kansas, Maine, West Virginia, and Puerto Rico. It was also distributed to numerous foreign countries, including Australia, Canada, China, Germany, India, and the United Kingdom. Users should stop using the product and contact Randox Laboratories for further instructions.
The recalled product
- Product
- Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
- Manufacturer
- Randox Laboratories Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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