Recall Z-2425-2024 ยท NDY Test, Cystatin C
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
| Date | Jul 24, 2024 (initiated Jun 7, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 115 kits |
| Distribution | US Nationwide distribution in the states of AL, CA, GA, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.