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

FDA device recall Z-2425-2024 · posted 2024-07-24 · Open, Classified

Recall details

Recalling firm

Randox Laboratories Ltd.

Reason for recall

Cystatin C Reagent marketed without a 510 (k)

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

Root cause

No Marketing Application

Status

Open, Classified

Product code

NDY

Quantity affected

115 kits

Distribution

US Nationwide distribution in the states of AL, CA, GA, NY.

Date initiated

2024-06-07

Date posted

2024-07-24

Location

Crumlin, North, Ireland