FDA (Devices) recall action 74950
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.
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.
Ortho-Clinical Diagnostics is recalling VITROS URIC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry LAC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Ortho-Clinical Diagnostics is recalling VITROS GLU Slides because certain substances, including N-Acetylcysteine, may interfere with glucose measurements.