Home / Recalls / Medical Devices
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total prote
Recalled February 15, 2017 · FDA recall Z-1179-2017 · Ortho-Clinical Diagnostics
Hazard
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides. · FDA Class II
Units
37,571 packs/90 slides totalling 3,381,390 slides
Sold at
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.
Description
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Product
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →