Z-1017-2025Class II

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated...

Name: Z-1017-2025 Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated...
Creator: Randox Laboratories, Limited
Published: 2024-12-20
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2024-12-20 / Open, Classified

FDA source

Randox Laboratories, Limited began a recall of Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403 on 2024-12-20. FDA classified it as Class II and gives the reason as "Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1017-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-20
Posted: 2025-01-23
Recalling firm: Randox Laboratories, Limited
Product: Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Product code: DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Reason for recall: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
FDA root cause: No Marketing Application
Action: Randox Laboratories Ltd (manufacturer) extended recall to the distribution center in the USA via email on 12/20/24. The distributor will then contact the customer directly via email. Letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any copies of Roche Cobas c501 ISA listing nmol/1 claims. " Ensure clinical results are no longer reported in nmol/1 using the Roche Cobas c501 nmol/1 claims. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns please contact Randox Technical Services.
Quantity in commerce: 15 kits
Distribution: US Nationwide distribution Including PR.
Product codes and lots: UDI-DI: 05055273204421 All lots within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1017-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1017-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-23
Z-1018-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-23

Product code DFC

K011568Class IIRandox LipoproteinRandox Laboratories, Ltd. / cleared 2001-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)