Randox Laboratories Ltd.: Device Recall
Recall #Z-2425-2024 · 06/07/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2425-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Randox Laboratories Ltd.
- Status
- Ongoing
- Date Initiated
- 06/07/2024
- Location
- Crumlin (North), Ireland
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115 kits
Reason for Recall
Cystatin C Reagent marketed without a 510 (k)
Product Description
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Distribution Pattern
US Nationwide distribution in the states of AL, CA, GA, NY.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.