Events

Recall of Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack for in vitro quantitative measurement.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Clinical Diagnostic Systems.

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
    79508
  • Event Risk Class
    Class 3
  • Event Number
    Z-1322-2018
  • Event Initiated Date
    2018-01-11
  • Event Date Posted
    2018-04-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162526
  • 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, thyroid-stimulating hormone - Product Code JLW
  • Reason
    Vitros tsh reagent lots have been found to generate higher than expected calibrator level 2 signals on some customer systems. these calibrator level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the customer calibration curve between calibrator level 2 and calibrator level 3.
  • Action
    Distributors instructed to disgard remaining inventory, complete Confirmation of Receipt form, and firm promised to replace product. Distributors instructed to send letter to customers.

Device

Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack for in vitro quantitative measu...
  • Model / Serial
    Lot 5470, expiry date: 24-May-2018 Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.) Lot 5178 was also affected by this issue, expired on 31-Mar-2017.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
  • Product Description
    VITROS Immunodiagnostic Products TSH Reagent Pack
  • Manufacturer
    Clinical Diagnostic Systems

Manufacturer

Clinical Diagnostic Systems
  • Manufacturer Address
    Clinical Diagnostic Systems, 601 Lee Rd Ny, Rochester NY 14652-0001
  • Manufacturer Parent Company (2017)
    Boule Diagnostics AB
  • Source
    USFDA