Events

Recall of VITROS Immunodiagnostic Products AntiHBs Calibrators & AntiHBs Reagent Packs

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
    66900
  • Event Risk Class
    Class 2
  • Event Number
    Z-0557-2014
  • Event Initiated Date
    2013-10-25
  • Event Date Posted
    2013-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124095
  • 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
    Hepatitis b (b core, be antigen, be antibody, be core igm) test - Product Code LOM
  • Reason
    Ortho clinical diagnostics issued a product correction notification for vitros immunodiagnostic products anti-hbs calibrators and anti-hbs quantitative reagent packs due to false positive results.
  • Action
    On October 25, 2013, Ortho Clinical Diagnostics issued product correction notifications to their US customers via US Postal Service Priority Mail and email notices to their foreign affiliates informing them of the recall. Ortho Clinical Diagnostics advised their customers to review previously reported results between > 12 and <30 mIU/mL and consult the Laboratory Medical Director. Customers were instructed to utilize alternative methods for anti-HBs testing. Customers are advised to seek alternative methods for anti-HBs testing. For additional information, please contact the OCD Customer Technical Service representative at 1-800-421-3311.

Device

VITROS Immunodiagnostic Products AntiHBs Calibrators & AntiHBs Reagent Packs
  • Model / Serial
    Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide distribution - all states.
  • Product Description
    VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
  • 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