FDA recall Z-0202-2024

Product

RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

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

Key facts

Status

Ongoing

Initiation date

2023-09-06

Report date

2023-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0202-2024