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Ortho-Clinical Diagnostics recalls VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier N
Recalled October 26, 2016 · FDA recall Z-0089-2017 · Ortho-Clinical Diagnostics
Hazard
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. · FDA Class II
Units
US: 192,459 sales units; Foreign: 231,710 sales units
Sold at
Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.
Description
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.
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) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →