Recall Z-2558-2019— Vital Scientific N.V.

Name: FDA recall Z-2558-2019
Creator: U.S. Food and Drug Administration
Published: 2016-01-18

Class II · Ongoing

Class II FDA medical device recall by Vital Scientific N.V., initiated 2016-01-18. It names one FDA 510(k) clearance: K973628. 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.. Reason: Instrument stopped working due to a software lockup, and no patient results are produced..

Recalling firm: Vital Scientific N.V.
Classification: Class II
Status: Ongoing
Initiated: 2016-01-18
Firm location: Dieren, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVAVital Scientific N.V.·cleared 1998-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.