The Recall Desk
ModerateFDA (Devices)·Z-0215-2016·Announced 2015-11-11

ELITech Eon 300 Reagents Recalled for Potential Drug Interference

ELITech Clinical Systems is recalling Eon 300 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 illness, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

ELITech Clinical Systems is recalling specific reagents used on the Eon 300 instrument system. The affected products include reagents for Glucose, Uric acid, Triglycerides, Cholesterol, Cholesterol HDL, and Cholesterol LDL. The recall is due to potential drug interference.

The recall covers 612 total units distributed nationwide in the United States. All lots are affected. The source text states that no complaints were received regarding this issue.

Healthcare facilities and laboratories should stop using the affected reagents and contact ELITech Clinical Systems for instructions on how to return or dispose of the products.

The recalled product

Product
Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL)
Manufacturer
ELITech Clinical Systems SAS
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
612

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.

See all 4 products in this recall →

Related recalls

Same manufacturer · ELITech Clinical Systems SAS

See all →

Same hazard · drug interference

See all →