Vital Scientific N.V.: Medical Device Recall in 2019 - (Recall #: Z-0547-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

Product Classification:

Class II

Date Initiated: November 15, 2018

Date Posted: December 4, 2019

Recall Number: Z-0547-2020

Event ID: 83910

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 732 instruments

Code Information:

(OUS) V-Twin¿ 6002-800 serial numbers from 3-3021 till 18-3345; (US) V-Twin¿6002-850 serial numbers from 3-3006 till 9-4037

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated