ELITech Eon 100 Reagents Recalled for Potential Drug Interference
ELITech Clinical Systems is recalling Eon 100 reagents due to potential drug interference. No complaints have been received.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that no complaints were received and the hazard is potential interference rather than a confirmed injury or high-risk pathogen, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
ELITech Clinical Systems is recalling specific reagents used on the Eon 100 instrument system. The recall involves 1,389 systems distributed nationwide in the United States. The affected products include reagents for Glucose, Uric acid, Triglycerides, Cholesterol, Cholesterol HDL, and Cholesterol LDL.
The recall is being conducted due to potential drug interference with the reagents. The source text states that no complaints were received regarding this issue.
Consumers and healthcare facilities should stop using the affected reagents and contact ELITech Clinical Systems for further instructions or a replacement.
The recalled product
- Product
- Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HD
- Manufacturer
- ELITech Clinical Systems SAS
- Hazard
- Affected units
- 1,389
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 lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by ELITech Clinical Systems SAS 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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