Reported Jul 31, 2024 · Ongoing
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated…
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North) · N/A
Is this the product you have?
- RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers
- Catalogue NumberCYS4004
- Lot codes and dates
- GTIN05055273208665 All lots
- Amount recalled
- 115 kits
Where it was sold
Why it was recalled
Cystatin C Reagent marketed without a 510 (k)
This product could cause temporary or reversible health problems — stop using it.
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