Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues
Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 2 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 moderate severity involving potential adverse health consequences or temporary harm.
Plain-English summary
Randox Laboratories Ltd. is recalling Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683. The firm confirmed that Free Kappa light chains in the product increase over the 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, as well as to numerous foreign countries. All lots are affected. Consumers and healthcare providers should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
- 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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