Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 05055273204421 All lots within expiry
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Randox Laboratories, Limited
- Reason for Recall:
- Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Product Codes/Lot Numbers:
UDI-DI: 05055273204421 All lots within expiry
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1017-2025
Related Recalls
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
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Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
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