The Recall Desk

FDA (Devices) recall action 73887

Ortho-Clinical Diagnostics recalled 2 products on 2016-06-15

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-06-15
Critical
0
Units
—

Why these products were recalled

Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2016-06-15

    Ortho VITROS 5600 System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 systems due to a software defect that may cause sample aspiration errors, leading to inaccurate or contaminated test results.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-06-15

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software timing anomaly that may cause the device to aspirate or dispense into unintended samples, potentially leading to erroneous or contaminated results.

    Product
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
    Category
    Distribution
    1 state