Device product
ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific pipetting protocols and ORTHO Assay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing.
Z-1651-2013
Product summary
- Event
- Event 65207
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31 units
- Official record key
device-enforcement:Z-1651-2013
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: 0811F06216 through 0811F06225 and 0911F06240 through 0911F06245 and 1011F06317 through 1011F06331
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
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.