Randox Laboratories Ltd.: RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution including Puerto Rico Quantity: O units Lot/code info: GTIN: 05055273214963 Lot/Batch Number:

UPC codes

05055273214963

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.