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 During in-house testing it was determined that their...

Date: November 15, 2018
Company: Vital Scientific N.V.
Status: Ongoing
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, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

Quantity: 732 instruments

Why Was This Recalled?

During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.

Where Was This Sold?

This product was distributed to 1 state: NY

Affected (1 state)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