The Recall Desk
HighFDA (Devices)·Z-0904-2023·Announced 2023-01-11

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.
Category
Medical Device — Laboratory Diagnostic Control Material
Hazard
  • potency-loss
  • quality-control-failure

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

Distributed nationwide across the United States.

Related recalls

Same category