RX Monaco-IVD Clinical Chemistry Analyser recallZ-0202-2024 · Randox Laboratories Ltd. · initiated Sep 6, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Randox issued Medical Device Correction letter (REC687) on 9/13/23 to to US and PR customers on 9/12/23. Letter states reason for recall, health risk and action to take: Randox recommendations: " Auto rerun settings are disabled, see Appendix A for guidance for each Rx instrument. " Results with flag(<) reported as the bottom of the technical range. Sample Volume settings Low should not be applied. " Results with flag (>) reported as the top of the technical range. Sample Volume settings high and dilutions should not be applied. A manual dilution should be performed, and results multiplied by the dilution factor. The RX Parameter rerun settings will be updated with a parameter release in due course, the Instructions For Use will also be updated at this time. Action to be taken: " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation.
Recall details
- Recall number
- Z-0202-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 6, 2023
- Posted by the FDA
- Oct 31, 2023
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 13 units
- Product code
- CGA
- Distribution
- US Nationwide distribution including Puerto Rico
Product description
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Code information (models, lots, serial numbers)
GTIN: 05055273207750 Lot/ Batch Number 230T240CS0126S 210T240CS0258S S180T240CS0486MA S180T240CS0487MA S180T240CS0483MA S180T240CS0218MA S170T240CS0665MA S160T240CS0111MA S160T240CS0110MA S150T240CS0005MA S140T240CS0185MA S140T240CS0017MA S140T240CS0015MA
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RX monaco RX5000Randox Laboratories Limited · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93102).
- Z-0198-2024 · Open, ClassifiedRX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
- Z-0199-2024 · Open, ClassifiedRX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
- Z-0200-2024 · Open, ClassifiedRX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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