FDA-Device2013-11-27Class II
VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
Ortho-Clinical Diagnostics
Hazard
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
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
12,484 units (9,040 units domestically & 3,444 units internationally)
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0307-2014Don't want to check this manually?
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