Events

Recall of Device Recall ORTHO Assay Software (OAS) Server

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho-Clinical Diagnostics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65207
  • Event Risk Class
    Class 2
  • Event Number
    Z-1651-2013
  • Event Initiated Date
    2013-05-06
  • Event Date Posted
    2013-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118744
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Test,equipment,automated bloodborne pathogen - Product Code MZA
  • 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.
  • Action
    Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letters dated May 6, 2013 and response forms to all affected customers. Ortho Clinical Diagnostics informed their customers of the issue and advised if they detect the smell of melting plastic or observe smoke originating from your VITROS¿ System, to immediately power down the system and contact OCD for assistance. They were also advised to consider performing the backup procedure more frequently to help prevent the loss of data on their Systems. In the near future, an OCD Field Engineer will contact customers who are affected and perform a Modification (MOD) procedure that will replace their potentially affected Wire Connector(s). Foreign affiliates were informed by email on May 6, 2013 of the issue and instructed to notify their customers of the issue and actions. OCD also found that this wire connector is commonly used in many types of computers (i.e., medical devices, personal computers, etc.). On 29 May 2013, OCD expanded their recall to incllude ORTHO Assay Software (OAS) Servers. As a precaution, OCD sent notifications to encompass all ORTHO¿ Assay Software (OAS) Servers that potentially contain this type of wire connector. The letters (Ref. CL13-154) were sent via US Priority Mail to all customers who were shipped an affected OAS Server. Ortho Clinical Diagnostics has requested that customers with any questions or in need of additional information, please call Customer Technical Services at 1-800-421-3311.

Device

Device Recall ORTHO Assay Software (OAS) Server
  • Model / Serial
    Serial numbers: 0811F06216 through 0811F06225 and 0911F06240 through 0911F06245 and 1011F06317 through 1011F06331
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    Not Classified
  • Implanted device?
    No
  • 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
  • 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.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA