Randox RX Imola Recalled Due to Sensor Malfunction and Internal Damage
Randox Laboratories is recalling 27 RX Imola instruments after a sensor malfunction caused internal wire melting and scorch damage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a malfunction resulting in physical damage (melting and scorching) to the device's internal structure, which aligns with the 'Severe' criteria for significant injury or property damage reports.
Plain-English summary
Randox Laboratories, Limited is recalling 27 units of the RX Imola, Model Nos. RX4900, medical device. The recall was initiated following a report of a sensor malfunction that resulted in an increase in temperature. This malfunction led to the melting of internal wires and scorch damage to the internal structure of the instrument.
The affected units were distributed domestically to California, Connecticut, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Utah, West Virginia, and Puerto Rico. The company also reported worldwide foreign distribution of the product. All serial numbers are included in this recall.
Consumers and healthcare facilities should stop using the affected RX Imola instruments and contact Randox Laboratories for further instructions on the recall process.
The recalled product
- Product
- RX Imola, Model Nos. RX4900
- Manufacturer
- Randox Laboratories, Limited
- Affected units
- 27
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories, Limited under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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