Events

Recall of Device Recall VITROS Immunodiagnostic Products NTpro BNP 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
    76665
  • Event Risk Class
    Class 2
  • Event Number
    Z-1765-2017
  • Event Initiated Date
    2017-03-07
  • 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=153781
  • 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
    Test,natriuretic peptide - Product Code NBC
  • Reason
    Increased frequency of calibration failures for vitros immunodiagnostic products nt-probnp reagent lots 1568, 1570, 1580 and 1590, due to background signals for these affected nt-probnp lots that have been increasing with time since release testing, resulting in higher than expected vitros immunodiagnostic products nt-probnp level 1 calibrator signals produced, leading to calibration failures.
  • Action
    On 3/7/2017, IMPORTANT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-048) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers and distributors who were shipped VITROS NT-proBNP Reagent Packs, Lots 1570, 1580 and/or 1590 to inform them of the issue and provided further instructions.

Device

Device Recall VITROS Immunodiagnostic Products NTpro BNP Reagent Pack
  • Model / Serial
    Lot 1570 (expiry 22 March 2017),  Lot 1580 (expiry 13 April 2017),  Lot 1590 (expiry 27 April 2017)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: United States, Puerto Rico, Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
  • Product Description
    VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
  • 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