Z-0201-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- September 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- O units
Product Description
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
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 Pattern
US Nationwide distribution including Puerto Rico
Code Information
GTIN: 05055273214963 Lot/Batch Number: