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Ortho-Clinical Diagnostics recalls VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Product
Recalled December 31, 2014 · FDA recall Z-0848-2015 · Ortho-Clinical Diagnostics
Hazard
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides. · FDA Class II
Units
USA: 380 units, Foreign: 155 units
Sold at
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Description
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
Product
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma 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 →