The Recall Desk
HighFDA (Devices)·Z-1018-2025·Announced 2025-01-29

Randox Lipoprotein (a) Diagnostic Assay Lacks FDA Clearance, Recalled

Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.

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 for diagnostic assay with unvalidated claims that lack required regulatory clearance. No illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm product without reported injury is classified as High (score 3).

Plain-English summary

Randox Laboratories, Limited is recalling 33 kits of the Randox Lipoprotein (a) diagnostic assay, Catalog Number LP2757 (UDI-DI: 05055273209198). This in vitro diagnostic (IVD) kit is used on automated laboratory analyzers.

The recall was initiated because the assay's claims for use on Roche Cobas c501 analyzers with nmol/l measurement units lack the required FDA clearance (510(k)) or approval (PMA).

The recall affects all lots that are still within their expiration date. Distribution includes nationwide coverage in the United States and Puerto Rico.

The recalled product

Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Manufacturer
Randox Laboratories, Limited
Category
Medical Device — In Vitro Diagnostic
Hazard
  • unvalidated-claims
  • missing-regulatory-clearance

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)

  • UDI-DI: 05055273209198 All lots within expiry

Distribution

Distributed nationwide across the United States.

Related recalls

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