Home / Recalls / Medical Devices
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitative
Recalled November 27, 2013 · FDA recall Z-0322-2014 · Ortho-Clinical Diagnostics
Hazard
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. · FDA Class II
Units
19,438 units (8,845 units domestically & 10,593 units internationally)
Sold at
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.
Description
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Product
VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →