Class II — Potential Health Hazard

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

V-Twin Recalled by Vital Scientific N.V. Due to The action is being initiated because the cooling...

Date: September 7, 2018
Company: Vital Scientific N.V.
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 Scientific N.V. directly.

Affected Products

V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

Quantity: 192 devices

Why Was This Recalled?

The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Vital Scientific N.V.

Vital Scientific N.V. has 8 total recalls tracked by RecallDetector.

Related Recalls

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