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Ortho-Clinical Diagnostics recalls VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure to
Recalled June 26, 2013 · FDA recall Z-1556-2013 · Ortho-Clinical Diagnostics
Hazard
The firm is recalling the specific lot due to lower than expected results. · FDA Class II
Units
478 total (339- Domestic) (139- International)
Sold at
Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
Description
The firm is recalling the specific lot due to lower than expected results.
Product
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →