Device product
VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Z-0312-2014
Product summary
- Event
- Event 65572
- Status
- Terminated
- Classification
- Class II
- Quantity
- 205,534 units (137,887 units domestically & 67,647 units internationally)
- Official record key
device-enforcement:Z-0312-2014
Official wording
Reason: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Code information: Multiple lots affected, with expiry dates through 22-Mar-2015
Distribution pattern: 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.
Derived failure modes
-
Unknown
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.