ClearanceBrief
Recall Z-1948-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Ortho-Clinical Diagnostics

Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.

DateJun 6, 2013
StatusTerminated
ReasonOrtho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
Root causeNonconforming Material/Component
ActionOrtho Clinical Diagnostics sent an Important Product Correction Notification letter dated June 6, 2013 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that an OCD trained service personnel will contact them and schedule a replacement of the CM/RT wear pads. OCD requested customers to complete and return the enclosed Confirmation of Receipt form no later than June 17, 2013. Customers are asked to place a copy of the notification by each VITROS System in their facility. Foreign affiliates were notified by
DistributionWorldwide Distribution - USA Nationwide in 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, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Puerto Rico and the countries of Me
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K031924VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
Ortho-Clinical Diagnostics, Aug 7, 2003
K063144VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
Ortho-Clinical Diagnostics, Inc., Nov 13, 2006
K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
Ortho-Clinical Diagnostics, Inc., Oct 23, 2008