Events

Recall of Device Recall VITROS AntiHBS Reagent Pack

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
    64739
  • Event Risk Class
    Class 3
  • Event Number
    Z-1161-2013
  • Event Initiated Date
    2012-11-01
  • Event Date Posted
    2013-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116884
  • 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, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • Reason
    Ortho clinical diagnostics is recalling certain lots of the vitros anti-hbs reagent packs an inability to obtain a valid calibration.
  • Action
    Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated November 1, 2012, to all affected customers via USPS. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue and discard any remaining recalled lots of VITROS Anti-HBS Reagent Packs. Foreign affiliates were informed by email on November 1, 2012, of the issue and instructed to notify their consignees of the issue and actions . On March 22, 2013, OCD sent customer letters via FedEX overnight and/or via USPS to US consignees for two additional lots of product being recalled. The letter provided similar recall instructions as the initial notification. Ortho Clinical Diagnostics has requested that their clients discontinue and discard any remaining inventory of VITROS Anti-HBS Reagent Packs subject to this recall. OCD has also requested that recall product recipients also complete a Confirmation of Receipt and return that document to OCD, fax to: 1-888-557-3759 or 585-453-4110. We apologize for any inconvenience this may cause your laboratory. If you have technical questions please contact Customer Technical Services at 1-800-421-3311. If you have questions about your replacement order, please call our Customer Service Center at 1-800-828-6316.

Device

Device Recall VITROS AntiHBS Reagent Pack
  • Model / Serial
    Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
  • Product Description
    VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs || For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
  • 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