RX Series CYSC- Cystatin C Reagent -Intended for in vitro… recallZ-2425-2024 · Randox Laboratories Ltd. · initiated Jun 7, 2024
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
Cystatin C Reagent marketed without a 510 (k)
FDA root cause category: No Marketing Application
What the company is doing
Randox issued Medical Deice Correction Letter (REC748) to end-users on 6/7/24 via email. Letter states reason for recall, health risk and action to take: Randox are discontinuing distribution of Cystatin C Reagent, Catalogue Number CYS4004 to and within United States of America and Puerto Rico, until further notice. NB The product is still performing as expected and there are no safety concerns with the functionality of the devices. This notification is strictly regulatory, as the affected devices require a new FDA Licence Action to be taken: Transmission of Customer Notification: Send a copy of the notification to all affected customers and to those who need to be aware within the organisation. Complete and return the response form (12187-QA) to [email protected] within five working days. If you have any questions or concerns, please contact Randox Technical Services
Recall details
- Recall number
- Z-2425-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 7, 2024
- Posted by the FDA
- Jul 24, 2024
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 115 kits
- Product code
- NDY
- Distribution
- US Nationwide distribution in the states of AL, CA, GA, NY.
Product description
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Code information (models, lots, serial numbers)
GTIN: 05055273208665 All lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CYSC CYS4004Randox Laboratories Limited · Test, Cystatin C1 recall0 reports
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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