RX Imola (RX4900) recallZ-2059-2018 · Randox Laboratories · initiated May 4, 2018
Terminated
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 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
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
FDA root cause category: Under Investigation by firm
What the company is doing
All customers will be contacted directly by email and will be followed up with once every 2 weeks over a period of 6 weeks. Customers are advised to update the software in all analyzers. For further questions, please call 1 (866)472-6369.
Recall details
- Recall number
- Z-2059-2018
- Status
- Terminated
- Initiated by the company
- May 4, 2018
- Recalling firm
- Randox Laboratories
- Quantity
- 41 analyzers
- Product code
- JJE
- FDA submissions
- K052914
- Distribution
- US Distribution including Puerto Rico and the state of : West Virginia.
Product description
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Code information (models, lots, serial numbers)
GTIN 05055273206104. All serial numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RX imola RX4900Randox Laboratories Limited · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use3 recalls0 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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