Randox Laboratories Ltd. Recall 93102
Description: RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Randox Laboratories Ltd. Recall 93102 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0201-2024 |
| Event ID | 93102 |
| Event Description | RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 |
| Product Type | Devices |
| Distribution | US Nationwide distribution including Puerto Rico |
| Quantity | O units |
| Recall 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. |
| Device Classification | 20231108 |
| Device Code Info | GTIN: 05055273214963 Lot/Batch Number: |
| Center Classification Date | 20231031 |
| Recall Initiation Date | 20230906 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | Letter |
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