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FDASeptember 6, 2023device

RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Ongoing

Brands named

randox laboratoriesrandox

UPCs

05055273214963

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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