RX Monaco-IVD Clinical Chemistry Analyser recall
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Why was RX Monaco-IVD Clinical Chemistry Analyser recalled?
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
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: 05055273207750 Lot/ Batch Number 230T240CS0126S 210T240CS0258S S180T240CS0486MA S180T240CS0487MA S180T240CS0483MA S180T240CS0218MA S170T240CS0665MA S160T240CS0111MA S160T240CS0110MA S150T240CS0005MA S140T240CS0185MA S140T240CS0017MA S140T240CS0015MA
- Product
- RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 13 units
- Distribution
- US Nationwide distribution including Puerto Rico
- Recall date
- November 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)