Recall Z-1018-2025— Randox Laboratories, Limited

Name: FDA recall Z-1018-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-20

Class II · Ongoing

Class II FDA medical device recall by Randox Laboratories, Limited, initiated 2024-12-20. It names one FDA 510(k) clearance: K011568. Product: Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757. Reason: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA..

Recalling firm: Randox Laboratories, Limited
Classification: Class II
Status: Ongoing
Initiated: 2024-12-20
Firm location: Crumlin, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K011568 — RANDOX LIPOPROTEINRandox Laboratories, Ltd.·cleared 2001-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

Reason for recall

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

Data sourced from openFDA. This site is unofficial and independent of the FDA.