Events

Recall of Device Recall VITROS Immunodiagnostics Products HBsAg 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
    37528
  • Event Risk Class
    Class 2
  • Event Number
    Z-0747-2007
  • Event Initiated Date
    2007-02-01
  • Event Date Posted
    2007-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50684
  • 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
    HBsAg Reagent Pack - Product Code LOM
  • Reason
    Complaints of an increase in ''reactive'' results with patient samples collected in sodium citrate or edta plasma collection tubes when using these lots of vitros hbsag reagent pack compared to samples collected in other tube types.
  • Action
    On 2/01/07, all US end-user consignees who received the VITROS HBsAg Reagent Packs, were informed of this issue by Federal Express overnight letter, and informed that they may continue to use their current lot of VITROS HBsAg Reagent Pack providing that they followed the instructions in the letter. INSTRUCTIONS: Please do the following if you choose to continue using sodium citrate and/or EDTA plasma collection tubes: - Do not freeze samples collected in sodium citrate or EDTA plasma collection tubes prior to processing the assay. - Process samples collected into sodium citrate plasma tubes within 12 hrs. of collection. -Continue to perform supplemental testing to confirm all HBsAg results that repeat as 'Borderline' or 'Reactive', as directed in the Package Insert. - Complete and return the attached Confirmation of Receipt Form upon receipt of this notification. - Forward the information in this notification if you have distributed the product outside your facility

Device

Device Recall VITROS Immunodiagnostics Products HBsAg Reagent Pack
  • Model / Serial
    Lots 6000 and 6030 thru 6120
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including Puerto Rico and countries of Tortola (British Virgin Islands) and Anguilla.
  • Product Description
    VITROS¿ Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, Forest Farm Estate, Whitechurch, Cardiff United Kingdom
  • Source
    USFDA