The Recall Desk

FDA (Devices) recall action 87019

Ortho Clinical Diagnostics Inc recalled 2 products on 2021-01-20

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
2021-01-20
Critical
0
Units
—

Why these products were recalled

Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

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

1–2 of 2

  • ModerateFDA (Devices)··2021-01-20

    Ortho VITROS Chemistry TP Slides Recalled for Eltrombopag Interference

    Ortho Clinical Diagnostics is recalling VITROS Chemistry TP Slides because the drug eltrombopag can interfere with total protein measurements.

    Product
    VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-01-20

    Ortho Clinical Diagnostics Recalls VITROS XT Chemistry Products ALB-TP Slides

    Ortho Clinical Diagnostics is recalling VITROS XT Chemistry Products ALB-TP Slides due to potential interference from the drug eltrombopag.

    Product
    VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
    Category
    Distribution
    0 states