Recall Z-1648-2013 · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Ortho-Clinical Diagnostics

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric

Date	Jul 2, 2013 (initiated May 6, 2013)
Status	Terminated
Reason	There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
Root cause	Device Design
Action	Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letters dated May 6, 2013 and response forms to all affected customers. Ortho Clinical Diagnostics informed their customers of the issue and advised if they detect the smell of melting plastic or observe smoke originating from your VITROS System, to immediately power down the system and contact OCD for assistance. They were also advised to consider performing the backup procedure more frequently to help prevent the loss of data on their Systems. In the near future, an OCD Field Engineer will contact customers who
Quantity	Total 69 units (28 units domestically and 41 units internationally)
Distribution	Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, J
FDA record	Open on fda.gov

510(k) clearances named in this recall

K031924

VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
Ortho-Clinical Diagnostics, Aug 7, 2003