Quality Control Material Potency Decline Causes Out-of-Range Laboratory Results
Randox Laboratories recalls a quality control product (PS2682) because Rheumatoid Factor concentration has declined, causing out-of-range quality control results and delayed laboratory test reporting.
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: FDA Class II defect in a quality control product where Rheumatoid Factor concentration has declined, causing out-of-range results. No illnesses or injuries have been reported. The defect is detectable through routine quality control monitoring, and the impact is primarily operational (delayed test reporting) rather than direct patient safety risk.
Plain-English summary
Randox Laboratories Ltd. is recalling Liquid Assayed Specific Protein Control Level 1 (Catalog PS2682), a quality control product used in clinical chemistry and immunoassay systems to validate analyzer performance. The recall affects 146 units distributed nationwide in California, Florida, Ohio, Maine, Missouri, North Carolina, New Jersey, Pennsylvania, and Tennessee. The affected lot numbers are 584LPC (expiration 28 June 2023), 600LPC (expiration 28 November 2023), and 611LPC (expiration 28 September 2024).
The recall was initiated because the concentration of Rheumatoid Factor in the control material has declined, causing quality control results to run outside the acceptable range when used on clinical analyzers. This out-of-range performance prevents proper validation of analyzer function.
When quality control values fall outside acceptable limits, laboratories are required to stop testing and investigate the discrepancy before resuming patient testing. This process delays the reporting of laboratory results. Laboratories using affected lot numbers should discontinue use and contact their supplier or Randox Laboratories for replacement product and proper handling instructions.
The recalled product
- Product
- Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- control-degradation
- assay-validation-risk
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: 05055273204896 Lot Number/Exp. Date: 584LPC 28th Jun 23
- 600LPC 28th Nov 23
- 611LPC 28th Sep 24
Distribution
Distributed nationwide across the United States.
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