medical Class II Updated 2023-11-08

Randox Laboratories Ltd. recalls RX Monaco-IVD Clinical Chemistry Analyser Catalog Number:

Recalled Product

RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 05055273207750 Lot/ Batch Number 230T240CS0126S 210T240CS0258S S180T240CS0486MA S180T240CS0487MA S180T240CS0483MA S180T240CS0218MA S170T240CS0665MA S160T240CS0111MA S160T240CS0110MA S150T240CS0005MA S140T240CS0185MA S140T240CS0017MA S140T240CS0015MA
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