Device product

RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

Z-0201-2024

September 06, 2023

Class II

Product summary

Firm: Randox Laboratories Ltd.
Event: Event 93102
Status: Ongoing
Classification: Class II
Quantity: O units
Official record key: device-enforcement:Z-0201-2024

Official wording

Reason: 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.

Code information: GTIN: 05055273214963 Lot/Batch Number:

Distribution pattern: US Nationwide distribution including Puerto Rico

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.