Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalo
Summary
The FDA issued a Class II for Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) by Randox Laboratories, Limited. Reason: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA..
Details
Source
Device Recall
External ID
Z-1018-2025
Action Date
2025-01-29
Status
Ongoing
Category
device
Product Description
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Lot/Code Info: UDI-DI: 05055273209198 All lots within expiry
Quantity Affected: 33 kits
Reason for Recall
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Distribution
US Nationwide distribution Including PR.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-20
Company
Crumlin
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Randox Laboratories, Limited has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Randox Laboratories, Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Randox Laboratories, Limited have FDA actions?
Randox Laboratories, Limited has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1018-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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