Vital Scientific N.V.: Medical Device Recall in 2019 - (Recall #: Z-0157-2020)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2019.
Data Source: FDA.
Product Description:
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Product Classification:
Class II
Date Initiated: January 10, 2012
Date Posted: October 23, 2019
Recall Number: Z-0157-2020
Event ID: 83582
Reason for Recall:
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Status: Terminated
Product Quantity: 5 instruments
Code Information:
serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.
Distribution Pattern:
US Nationwide in the states of NY, and UT
Voluntary or Mandated:
Voluntary: Firm initiated