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.
FDA Recall Z-2558-2019 · Posted None
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Recalling FirmVital Scientific N.V.
Recall StatusOpen, Classified
Product CodeJJF
Date Initiated2016-01-18
Product Quantity2
Reason for Recall
Instrument stopped working due to a software lockup, and no patient results are produced.
Firm 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.
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
US in the state of New York.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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