FDA recall Z-1017-2025

Randox Laboratories, Limited · Class II · device

Product

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

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.

Key facts

Status
Ongoing
Initiation date
2024-12-20
Report date
2025-01-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Crumlin, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2025