FDA-Device2017-02-15Class II

VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

Ortho-Clinical Diagnostics
Hazard

There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.

Sold states
Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Affected count
37,571 packs/90 slides totalling 3,381,390 slides
Manufactured in
513 Technology Blvd, N/A, Rochester, NY, United States
Products
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1179-2017

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