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
Reported: July 10, 2013 Initiated: May 6, 2013 #Z-1650-2013
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- Total 98 units (30 units domestically & 68 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, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ortho-Clinical Diagnostics. Units affected: Total 98 units (30 units domestically & 68 units internationally).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2013. Severity: Moderate. Recall number: Z-1650-2013.
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