FDA Enforcement
Class II
Ongoing
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Recall: Z-0199-2024
·
Reported November 8, 2023
Enforcement
- Recall Number
- Z-0199-2024
- Event ID
- 93102
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Randox Laboratories Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 8, 2023
- Initiation Date
- September 6, 2023
- Classification Date
- October 31, 2023
- Address
- 55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland
Description
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
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 Info
GTIN: 05055273207781 Lot/Batch: (1) 7241-0616 7241-0582 7241-0441 7241-0425 7241-0384 RX4041R: Lot Number: (2) 7241-0149
Distribution
US Nationwide distribution including Puerto Rico
Quantity
6 units