FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: 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 number
- Z-2425-2024
- Recalling firm
- Randox Laboratories Ltd.
- 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
- Status
- Open, Classified
- Initiated
- 2024-06-07
- Posted
- 2024-07-24
- Terminated
- not on file
- Reason
- Cystatin C Reagent marketed without a 510 (k)
- 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 technical.services@randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services
- Quantity
- 115 kits
- Distribution
- US Nationwide distribution in the states of AL, CA, GA, NY.
- Lot, serial or model codes
- GTIN: 05055273208665 All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDY
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06