medical Class II Updated 2023-11-08

Randox Laboratories Ltd. recalls RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analys

Recalled Product

RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)

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: 05055273207781 Lot/Batch: (1) 7241-0616 7241-0582 7241-0441 7241-0425 7241-0384 RX4041R: Lot Number: (2) 7241-0149
View official government recall

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