Randox Laboratories Ltd.: RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040

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: 5 units Lot/code info: GTIN: 05055273207774 Lot/ Batch Number (1) Lot/ Batch Number 7241-0551 7241-0545 7241-0531 7241-0317 7241-0219

UPC codes

05055273207774

Source

Official record: FDA (Device enforcement) ↗

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