Z-2425-2024Class II

RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on...

Name: Z-2425-2024 RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on...
Creator: Randox Laboratories Ltd.
Published: 2024-06-07
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2024-06-07 / Open, Classified

FDA source

Randox Laboratories Ltd. began a recall of RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004 on 2024-06-07. FDA classified it as Class II and gives the reason as "Cystatin C Reagent marketed without a 510 (k)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2425-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-07
Posted: 2024-07-24
Recalling firm: Randox Laboratories, Limited
Product: RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Product code: NDY Test, Cystatin C
Reason for recall: Cystatin C Reagent marketed without a 510 (k)
FDA root cause: No Marketing Application
Action: Randox issued Medical Deice Correction Letter (REC748) to end-users on 6/7/24 via email. Letter states reason for recall, health risk and action to take: Randox are discontinuing distribution of Cystatin C Reagent, Catalogue Number CYS4004 to and within United States of America and Puerto Rico, until further notice. NB The product is still performing as expected and there are no safety concerns with the functionality of the devices. This notification is strictly regulatory, as the affected devices require a new FDA Licence Action to be taken: Transmission of Customer Notification: Send a copy of the notification to all affected customers and to those who need to be aware within the organisation. Complete and return the response form (12187-QA) to [email protected] within five working days. If you have any questions or concerns, please contact Randox Technical Services
Quantity in commerce: 115 kits
Distribution: US Nationwide distribution in the states of AL, CA, GA, NY.
Product codes and lots: GTIN: 05055273208665 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2425-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2425-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-24

Product code NDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)