Home / Recalls / Vital Scientific N.V. / Z-0155-2020

Z-0155-2020 Class II Terminated

Recalled by Vital Scientific N.V. — Dieren, N/A

Recall Details

Product Type
Devices
Report Date
October 23, 2019
Initiation Date
January 10, 2012
Termination Date
April 19, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
75 units

Product Description

Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

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.

Distribution Pattern

US Nationwide in the states of NY, and UT

Code Information

serial numbers: 10-4582 till 10-4584; 10-4586 till 10-4594; 11-2309; 11-2320 t through 11-2328; 11-2330 through-2334; 11-2336 through 11-2375; 11-2383; 11-2384; 11-2388; 11-2395; 12-2314; 12-2315; 12-2324 12-2325.

Other recalls by Vital Scientific N.V.

  • Z-0547-2020 Class II — V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 (November 15, 2018)
  • Z-0038-2020 Class II — V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro dia (September 7, 2018)
  • Z-2558-2019 Class II — V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro dia (January 18, 2016)
  • Z-0157-2020 Class II — Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 60 (January 10, 2012)
  • Z-0156-2020 Class II — V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated c (January 10, 2012)
  • Z-0158-2020 Class II — Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage (January 10, 2012)
  • Z-0154-2020 Class II — Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automa (January 10, 2012)