Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues
Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 3 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a delay in diagnostic results for serious conditions like Multiple Myeloma, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Randox Laboratories Ltd. is recalling Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684. The firm confirmed that Free Kappa light chains in the product increase over the shelf life. This product is used as an aid in the diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through the review of the ratio with free lambda chains.
The increase in Free Kappa light chains may lead to a delay in reporting Free Kappa Light Chains results. The recall covers all lots of the product.
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, Japan, and the United Kingdom. Users should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
- 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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