RX Series CYSC- Cystatin C Reagent -Intended for in recall
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number…
Why was RX Series CYSC- Cystatin C Reagent -Intended for in recalled?
Cystatin C Reagent marketed without a 510 (k)
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 05055273208665 All lots
- Product
- RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 115 kits
- Distribution
- US Nationwide distribution in the states of AL, CA, GA, NY.
- Recall date
- July 31, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)