Laboratory quality control material with degraded potency affecting diagnostic verification
Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.
What this means for you
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: FDA Class II device recall with no reported illnesses or injuries. The hazard is potency loss in a diagnostic control product, creating a risk of compromised quality control that could lead to delayed or missed test results. This qualifies as a risk-of-harm product without reported injury.
Plain-English summary
Randox Laboratories Ltd. is recalling Liquid Assayed Specific Protein Control Level 2 (Catalog PS2683), a quality control material used in clinical laboratories. The product is designed to help verify that laboratory equipment used for serum testing and immunoassays is functioning correctly.
The recall occurs because the concentration of rheumatoid factor in the product has decreased, causing laboratory quality control tests to fail or run outside acceptable ranges. This prevents laboratories from verifying that their equipment is working properly before reporting results to patients.
Affected lot numbers are 585LPC (June 28, 2023 expiration), 601LPC (November 28, 2023 expiration), and 612LPC (September 28, 2024 expiration). A total of 115 units were distributed nationwide to laboratories in California, Florida, Ohio, Maine, Missouri, North Carolina, New Jersey, Pennsylvania, and Tennessee.
Affected laboratories should immediately discontinue use of the recalled control materials and contact Randox Laboratories for replacement product or additional information about the recall.
The recalled product
- Product
- Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 115
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 (2)
- 601LPC 28th Nov 23
- 612LPC 28th Sep 24
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 · potency loss
See all →- HighNeupogen Injectable Drug Recalled for Potential Stability Issues at Expiration
FDA (Drugs) · 2025-03-26
- HighInjectable Drug Recalled for Stability Issues at Expiration
FDA (Drugs) · 2025-03-26
- HighInjectable drug recalled for temperature excursion during storage
FDA (Drugs) · 2024-12-18
- HighBD Bacterial Susceptibility Test Discs Recall for Decreased Potency
FDA (Devices) · 2024-12-11
- HighRespiratory inhalation medication recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03