FDA Device Intelligence
Home › VitalScientific B.V. › V-Twin®

V-Twin®

VitalScientific B.V. · Model 6002-800 · UDI-DI 03661540600180

JJF
10
510(k) clearances
93
Adverse events
13
Recalls
32
Facilities

Recalls

DateFirmReason
2018-11-15Vital Scientific N.V.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
2018-09-07Vital Scientific N.V.The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the co
2016-01-18Vital Scientific N.V.Instrument stopped working due to a software lockup, and no patient results are produced.
2012-02-01Roche Molecular Systems, Inc.Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence,
2012-01-10Vital Scientific N.V.The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
2012-01-10Vital Scientific N.V.The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
2012-01-10Vital Scientific N.V.The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
2007-08-30Roche Diagnostics Corp.False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries sh
2007-05-21Roche Molecular Systems, Inc.For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent sta
2005-11-23Beckman Coulter IncUnder certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.