Ortho-Clinical Diagnostics recalls VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier N…

Recall date

August 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0089-2017

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

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.

Why it was 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 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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