medical Class II Updated 2023-11-08

Randox Laboratories Ltd. recalls RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser

Recalled Product

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


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: 05055273207774 Lot/ Batch Number (1) Lot/ Batch Number 7241-0551 7241-0545 7241-0531 7241-0317 7241-0219
View official government recall

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