The Recall Desk
ModerateFDA (Devices)·Z-0217-2016·Announced 2015-11-11

ELITech Envoy 500 Reagent Kits Recalled for Potential Drug Interference

ELITech Clinical Systems is recalling Envoy 500 reagent kits 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 no complaints were received and the hazard is potential interference rather than reported injury, fitting the Moderate criteria for low-risk or theoretical hazards.

Plain-English summary

ELITech Clinical Systems SAS is recalling specific reagent kits used with the Envoy 500 instrument system. The affected products include reagents for Glucose, Uric Acid, Triglycerides, Cholesterol, Creatinine, HDL Cholesterol, and LDL Cholesterol. The recall involves 13,455 systems distributed nationwide in the United States, covering all lots.

The recall was initiated due to potential drug interference with the Trinder reaction-based reagents. This issue could affect the accuracy of test results. The source text states that no complaints were received regarding this issue.

Healthcare providers and laboratories using the Envoy 500 system should stop using the affected reagent kits and contact ELITech Clinical Systems for further instructions or replacements.

The recalled product

Product
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENV
Manufacturer
ELITech Clinical Systems SAS
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
13,455

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 →

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