The Recall Desk

FDA (Devices) recall action 83582

Vital Scientific N.V. recalled 5 products on 2019-10-23

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2019-10-23
Critical
0
Units
129

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2019-10-23

    Vital Scientific Selectra ProM Analyzer Recalled for Power Supply Failure

    Vital Scientific N.V. is recalling five Selectra ProM Analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.

    Product
    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.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-10-23

    Vital Scientific Selectra ProS Analyzer Recalled for Power Supply Failure

    Vital Scientific is recalling six Selectra ProS Analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.

    Product
    Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-10-23

    Vital Scientific Viva-E Automated Chemistry Analyzer Recalled for Power Supply Failure

    Vital Scientific N.V. is recalling 75 Viva-E automated chemistry analyzers due to power supply failures that prevent the instruments from producing patient results.

    Product
    Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-10-23

    Vital Scientific V-Twin Automated Chemistry Analyzer Recalled for Power Supply Failure

    Vital Scientific N.V. is recalling 39 V-Twin automated chemistry analyzers due to a power supply failure that prevents the instruments from producing patient results.

    Product
    V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-10-23

    Vital Scientific Viva-JR Automated Chemistry Analyzer Recalled for Power Supply Failure

    Vital Scientific N.V. is recalling four Viva-JR automated chemistry analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.

    Product
    Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
    Category
    Distribution
    2 states