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Recall Observatory FDA recall evidence

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

May 06, 2013

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
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

    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.