FDA-Device2019-08-14Class II
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
Ortho-Clinical Diagnostics
Hazard
Potentially Biased Results using VITROS Chemistry Products GLU Slides
Sold states
US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
Affected count
1099 (5 pack x 60)=329700 slides
Manufactured in
513 Technology Blvd, N/A, Rochester, NY, United States
Products
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2202-2019Don't want to check this manually?
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