Cystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
Randox Laboratories is recalling 115 kits of RX Series CYSC Cystatin C Reagent because it was marketed without required FDA 510(k) clearance. Healthcare facilities should discontinue use and contact the manufacturer.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall addresses a regulatory compliance violation—marketing without required 510(k) premarket clearance—with no reported illnesses, injuries, or adverse events documented in the source text. Per the rubric, when illnesses/injuries are not reported and the hazard is regulatory rather than documented harm, a Moderate score applies.
Plain-English summary
The RX Series CYSC Cystatin C Reagent is an in vitro diagnostic reagent intended for use on automated laboratory analyzers to measure cystatin C levels in patient samples. It is manufactured by Randox Laboratories Ltd.
This product was marketed and distributed in the United States without the required FDA 510(k) premarket clearance. The 510(k) process establishes that a medical device is substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness.
Approximately 115 kits were distributed nationwide to healthcare facilities in Alabama, California, Georgia, and New York (GTIN 05055273208665, all lot numbers affected).
Healthcare facilities that have received this product should discontinue use immediately and contact Randox Laboratories Ltd. for instructions on return or replacement with an FDA-cleared alternative.
The recalled product
- 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
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- uncleared-device
- regulatory-violation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 05055273208665 All lots
Distribution
Distributed nationwide across the United States.
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