RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Reported: November 8, 2023 Initiated: September 6, 2023 #Z-0202-2024
Product Description
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.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 13 units
- Distribution
- US Nationwide distribution including Puerto Rico
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000. Recalled by Randox Laboratories Ltd.. Units affected: 13 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 8, 2023. Severity: Moderate. Recall number: Z-0202-2024.
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