Randox Lipoprotein (a) assay distributed without required FDA clearance
Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.
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: This is an FDA Class II recall for a diagnostic assay distributed without required regulatory clearance (510(k) or PMA). While no illnesses or injuries have been reported, the product qualifies as a risk-of-harm item due to potential for unvalidated test results affecting clinical decisions.
Plain-English summary
Randox Laboratories, Limited is recalling Randox Lipoprotein (a) assay kits (Catalog Number LP3403) for use on Roche Cobas c501 automated analyzers. Fifteen kits were distributed nationwide in the United States, including Puerto Rico.
The product was marketed with claims regarding nanomoles per liter (nmol/l) measurements without required FDA regulatory clearance. The assay lacks either a 510(k) substantial equivalence determination or Premarket Approval (PMA), both of which are required before diagnostic tests can be legally marketed in the United States.
Healthcare facilities and laboratories using Roche Cobas c501 analyzers may have received this unvalidated product. The lack of regulatory validation means the assay's accuracy and reliability have not been formally confirmed by FDA.
The recalled product
- Product
- Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
- Manufacturer
- Randox Laboratories, Limited
- Hazard
- unvalidated-diagnostic
- regulatory-non-compliance
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: 05055273204421 All lots within expiry
Distribution
Distributed nationwide across the United States.
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