Events

Recall of Device Recall VITROS Immunodiagnostic Products Signal Reagent

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
    71176
  • Event Risk Class
    Class 3
  • Event Number
    Z-1707-2015
  • Event Initiated Date
    2015-05-06
  • Event Date Posted
    2015-06-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136367
  • 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
    Radioimmunoassay, total triiodothyronine - Product Code CDP
  • Reason
    The immunodiagnostic products signal reagent, lot 3082 as the reagent packs may contain blank labels.
  • Action
    On 5/06/2015, Customer Letter and Verification Form (Ref. CL15-095) were sent notifying the users of the issue and advised them of the required actions. The notification was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. On 5/06/2015, Distributor Letter (Ref. DL15-095) was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and actions. For questions,questions, please contact Customer Technical Services at 1-800-421-3311 at any time.

Device

Device Recall VITROS Immunodiagnostic Products Signal Reagent
  • Model / Serial
    Lot 3082, expiry date 7/27/2015
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
  • 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