FDA Medical devices recall ·
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox… recall
- Recall number
- Z-1017-2025
- Date
- (initiated December 20, 2024)
- Company / brand
- Randox Laboratories, Limited
Ardmore; 55 The Diamond Road, Crumlin, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Why was it recalled?
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 05055273204421 All lots within expiry
Distribution
US Nationwide distribution Including PR.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1017-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.