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Recall Observatory FDA recall evidence

Device product

V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

Z-0156-2020

January 10, 2012

Class II

Product summary

Firm
Vital Scientific N.V.
Event
Event 83582
Status
Terminated
Classification
Class II
Quantity
39 instruments
Official record key
device-enforcement:Z-0156-2020

Official wording

Reason: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Code information: serial numbers: 10-3331; 10-3332; 11-3301; 11-3304 through 11-3306; 11-3308 through 11-3312; 11-3315; 11-3316; 11-3318 through 11-3342; 12-3302.

Distribution pattern: US Nationwide in the states of NY, and UT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.