The Recall Desk

FDA (Devices) recall action 74950

Ortho-Clinical Diagnostics recalled 4 products on 2016-10-26

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-10-26
Critical
0
Units
—

Why these products were recalled

Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.

Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. Ortho also tested several compounds following industry standard CLSI EP7-A2 for potential interference on VITROS GLU Slides during validation testing for a proposed change and confirmed Dextran 40 and Glutathione may interfere with current VITROS GLU Slides.

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

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2016-10-26

    Ortho-Clinical VITROS Chemistry TRIG Slides Recalled Due to NAC Interference

    Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides because N-Acetylcysteine (NAC) can interfere with the assay results.

    Product
    VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-10-26

    Ortho-Clinical VITROS Chemistry LAC Slides Recalled Due to NAC Interference

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry LAC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.

    Product
    VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-10-26

    Ortho VITROS URIC Slides Recalled Due to NAC Interference

    Ortho-Clinical Diagnostics is recalling VITROS URIC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.

    Product
    VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-10-26

    Ortho VITROS Chemistry GLU Slides Recalled for Potential Assay Interference

    Ortho-Clinical Diagnostics is recalling VITROS GLU Slides because certain substances, including N-Acetylcysteine, may interfere with glucose measurements.

    Product
    VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU)…
    Category
    Distribution
    1 state