FDA-Device2013-11-27Class II
VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Ortho-Clinical Diagnostics
Hazard
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Sold states
Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.
Affected count
11,135 units (153 units domestically & 10,982 internationally)
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0303-2014Don't want to check this manually?
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