FDAFDA · Food and drugs·Recall number Z-2425-2024
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Published July 31, 2024 · Recall initiated: June 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cystatin C Reagent marketed without a 510 (k)
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- US Nationwide distribution in the states of AL, CA, GA, NY.
- Lot
- GTIN: 05055273208665 All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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