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Recall Observatory FDA recall evidence

Device product

1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Z-1647-2013

May 06, 2013

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 65207
Status
Terminated
Classification
Class II
Quantity
Total 101 units (84 units for # 6801375- 26 units domestic & 58 units foreign) and (17 units for # 6801890-15 units domestic, 2 units foreign)
Official record key
device-enforcement:Z-1647-2013

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: 1) J34000240, J34000714, J34001562 and J34002163 through J34002245, 2) 34000193, 34000420, 34000478, 34000495, 34000497, 34000529, 34000596, 34000799, 34000805, 34000947, 34001243, 34001422, 34001504, 34001569, 34001589, 34001610, 34001633

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.