Ortho-Clinical Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-1651-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 6, 2013

Date Posted: July 10, 2013

Recall Number: Z-1651-2013

Event ID: 65207

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.

Status: Terminated

Product Quantity: 31 units

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

Voluntary or Mandated:

Voluntary: Firm initiated