Recall Z-2425-2024
Randox Laboratories Ltd. · initiated June 7, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: GTIN: 05055273208665 All lots
Reason for recall
Cystatin C Reagent marketed without a 510 (k)
FDA-determined cause: No Marketing Application
Action taken
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
Details
- Recall number
- Z-2425-2024
- Initiated
- June 7, 2024
- Posted by FDA
- July 24, 2024
- Product code
- NDY – Test, Cystatin C
- Quantity
- 115 kits
- Distribution
- US Nationwide distribution in the states of AL, CA, GA, NY.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North