Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN Recalled by Vital Diagnostics, Inc. Due to High positive calcium bias on plasma sample versus...

Date: August 29, 2013
Company: Vital Diagnostics, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Vital Diagnostics, Inc. directly.

Affected Products

Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum

Quantity: 395 units

Why Was This Recalled?

High positive calcium bias on plasma sample versus results on serum

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Vital Diagnostics, Inc.

Vital Diagnostics, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report