Events

Recall of VITROS Immunodiagnostic Products AntiHCV 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
    68974
  • Event Risk Class
    Class 2
  • Event Number
    Z-2671-2014
  • Event Initiated Date
    2014-08-06
  • Event Date Posted
    2014-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129189
  • 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
    Assay,enzyme linked immunosorbent,hepatitis c virus - Product Code MZO
  • Reason
    Vitros immunodiagnostic products anti-hcv kit lot 9090 has been observed producing sporadic lower than expected vitros anti-hcv test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).
  • Action
    All US consignees (users) who were shipped the affected lot VITROS HCV Reagent Pack were sent communications via FedEx and/or US Priority Mail (PO Boxes only) on 8/06/14, and advised of the issue and to immediately discontinue using all remaining inventory of VITROS Anti-HCV Reagent Packs Lot 9090. For additional information, please contact OCD's Customer Technical Service representatives at 1-800-421-3311.

Device

VITROS Immunodiagnostic Products AntiHCV Reagent Pack
  • Model / Serial
    Lot 9090 (exp. December 15, 2014)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    NY, NJ, CT, MA, PA, VA, MD, FL and GA
  • Product Description
    VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS
  • Manufacturer Address
    ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA