Randox Lipoprotein recall
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Why was Randox Lipoprotein recalled?
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 05055273209198 All lots within expiry
- Product
- Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
- Recalling firm
- Randox Laboratories, Limited
- Quantity
- 33 kits
- Distribution
- US Nationwide distribution Including PR.
- Recall date
- January 29, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)