medical Class II Updated 2023-11-08

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

Recalled Product

RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

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: 05055273214963 Lot/Batch Number:
View official government recall

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