The Recall Desk

FDA (Devices) recall action 86070

Ortho-Clinical Diagnostics recalled 3 products on 2020-09-02

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-09-02
Critical
0
Units
—

Why these products were recalled

Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

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

1–3 of 3

  • HighFDA (Devices)··2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS TBIL Slides Due to Etrombopag Interference

    Ortho-Clinical Diagnostics is recalling VITROS TBIL Slides because the drug etrombopag can interfere with test results, potentially leading to inaccurate total bilirubin measurements.

    Product
    VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS XT Chemistry TBIL-ALKP Slides

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin test results.

    Product
    VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-09-02

    Ortho-Clinical VITROS Chemistry BuBc Slides Recalled for Etrombopag Interference

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BuBc Slides because the drug etrombopag interferes with the test results.

    Product
    VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
    Category
    Distribution
    0 states