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Recall Observatory FDA recall evidence

Device product

VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

Z-1650-2013

May 06, 2013

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 65207
Status
Terminated
Classification
Class II
Quantity
Total 98 units (30 units domestically & 68 units internationally)
Official record key
device-enforcement:Z-1650-2013

Official wording

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.

Code information: Serial numbers: J36000111 and J36000520 through J36000617

Distribution pattern: 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, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.