Randox Protein Control Material Concentration Decreased, Affecting Quality Control
Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 3 (catalog PS2684) because the concentration of rheumatoid factor has decreased, causing quality control systems to run outside acceptable ranges and delaying test result reporting.
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 recall with no reported hospitalizations or patient illnesses. The degraded control material poses a risk of diagnostic errors and test reporting delays, meeting the threshold for risk-of-harm products without reported patient harm.
Plain-English summary
Randox Laboratories Ltd. is recalling Liquid Assayed Specific Protein Control Level 3 (catalog number PS2684), an in vitro diagnostic quality control reagent used in clinical chemistry and immunoassay systems. The recall affects 49 units distributed nationwide in California, Florida, Ohio, Maine, Missouri, North Carolina, New Jersey, Pennsylvania, and Tennessee.
The concentration of rheumatoid factor in the control material has decreased below acceptable levels. This causes quality control systems to operate outside their specified ranges, which can result in delays to laboratory test result reporting.
Affected lot numbers are 586LPC (expiration 28 June 2023), 602LPC (expiration 28 November 2023), and 628LPC (expiration 28 December 2024). Clinical laboratories using affected lots should contact Randox Laboratories for product replacement or guidance. No patient illnesses or injuries related to this issue have been reported to the FDA.
The recalled product
- Product
- Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- degradation
- quality-control-failure
- diagnostic-delay
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 (3)
- GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23
- 602LPC 28th Nov 23
- 628LPC 28th Dec 24
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27