Oct

2019

Recall – IVD software issue leads to lockup and no patient results

Company: Vital Scientific N.V.
Date of Enforcement Report: 10/2/2019
Class II

PRODUCT

V-Twin, Model # 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.

Recall Number: Z-2558-2019

REASON

Instrument stopped working due to a software lockup, and no patient results are produced.

RECALLING FIRM/MANUFACTURER

Vital Scientific N.V. on 1/18/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION

US in the state of New York.

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Recall – IVD software issue leads to lockup and no patient results

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