Vital Scientific N.V. recalls V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

Recall date

November 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0547-2020

FDA classification

Class II

Brand / firm

Vital Scientific N.V.

Sold / distributed

NY

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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