FDA-Device2014-01-29Class II
VITROS Chemistry Products COCM Reagent
Ortho-Clinical Diagnostics
Hazard
Inaccurate quality control results.
Sold states
Worldwide Distribution. US nationwide (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico), Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
Affected count
3,342 units
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS Chemistry Products COCM Reagent
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0817-2014Don't want to check this manually?
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