Recall Z-1088-2014 ยท JIX Calibrator, Multi-Analyte Mixture
Ortho-Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG.
| Date | Feb 25, 2014 (initiated Oct 17, 2013) |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results. |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated October 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Ortho Clinical Diagnostics recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample. Please forward a copy of the notification letter if the products were further distributed. Complete and return the attached Confirmation of Receipt form by October 25, 2013. Customers with questions please call Customer Tech |
| Quantity | 19,368 units total (10,328 for lot 212 and 9,040 for lot 292) |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of 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, WA, WI, WV and WY., and the countries of |
| FDA record | Open on fda.gov |