Z-2558-2019Class II

V-Twin, Model # 6002-800, UDI: 03661540600180

Name: Z-2558-2019 V-Twin, Model # 6002-800, UDI: 03661540600180
Creator: Vital Scientific N.V.
Published: 2016-01-18
License: https://open.fda.gov/license/

VitalScientific / initiated 2016-01-18 / Open, Classified / root cause: software

FDA source

Vital Scientific N.V. began a recall of V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for... on 2016-01-18. FDA classified it as Class II and gives the reason as "Instrument stopped working due to a software lockup, and no patient results are produced". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2558-2019
Classification: Class II
Status: Open, Classified
Initiated: 2016-01-18
Posted: 2019-09-23
Recalling firm: VitalScientific
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.
Product code: JJF Analyzer, Chemistry, Micro, For Clinical Use
Reason for recall: Instrument stopped working due to a software lockup, and no patient results are produced.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: In very close cooperation with the consignees, the affected end users running on EPROM version V1.2.3 were contacted. Initially, a temporary work around (reset of the software) was communicated with the consignees. The consignees devices were installed to document all errors during runtime .In addition, a new software was developed and tested. The new software resulted in version 1.2.5 of EPROM, which was released June 23, 2016. Consignees of the V-Twin all received a field update kit with the new software.
Quantity in commerce: 2
Distribution: US in the state of New York.
Product codes and lots: Serial #s: 13-3341 and 13-3344

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2558-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2558-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-10-02	2019-09-23

Product code JJF

K973628Class IVitalab Flexor/vitalab Selectra 2/Vitalab VivaVital Scientific N.V. / cleared 1998-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)