Recall Z-2425-2024— Randox Laboratories Ltd.
Class II · Ongoing
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2024-06-07. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Cystatin C Reagent marketed without a 510 (k).
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-07
- Firm location
- Crumlin (North), Ireland
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
Reason for recall
Cystatin C Reagent marketed without a 510 (k)
Data sourced from openFDA. This site is unofficial and independent of the FDA.