Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
GTIN: 05055273208665 All lots
Products Sold
GTIN: 05055273208665 All lots
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C due to Cystatin C Reagent marketed without a 510 (k). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cystatin C Reagent marketed without a 510 (k)
Recommended Action
Per FDA guidance
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 technical.services@randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026