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.
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 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Randox Laboratories Ltd.
See all →- ModerateCystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
FDA (Devices) · 2024-07-31
- ModerateEvidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy
FDA (Devices) · 2024-05-15
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15
- HighMicroalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification
FDA (Devices) · 2024-04-24
- HighMicroalbumin Calibrator Series Recall Due to Measurement Accuracy Issue
FDA (Devices) · 2024-04-24
Same hazard · diagnostic delay
See all →- ModerateCulture media quality control kits contain the wrong bacterial organism
FDA (Devices) · 2025-07-23
- HighBeckman Coulter Sample Probes with Defective Tips Clinical Chemistry
FDA (Devices) · 2025-06-11
- HighDxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment
FDA (Devices) · 2025-03-26
- ModerateBeckman Coulter Urine Chemistry Controls May Produce False Positive Results
FDA (Devices) · 2024-10-23
- HighMRI Diagnostic Device Loose Screws May Block Patient Tabletop
FDA (Devices) · 2024-10-02