Z-0199-2024 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
- 6 units
Product Description
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
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: 05055273207781 Lot/Batch: (1) 7241-0616 7241-0582 7241-0441 7241-0425 7241-0384 RX4041R: Lot Number: (2) 7241-0149