Events

Recall of VITROS Chemistry Products COCM 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
    66474
  • Event Risk Class
    Class 2
  • Event Number
    Z-0817-2014
  • Event Initiated Date
    2013-10-04
  • Event Date Posted
    2014-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122450
  • 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
    Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
  • Reason
    Inaccurate quality control results.
  • Action
    On October 4, 2013 Ortho Clinical Diagnostics issued a Product Correction Notification to customers via US Postal Service Priority Mail or FedEx regarding VITROS Chemistry Products COCM Reagent due to inaccurate quality control results. Ortho Clinical Diagnostics advised their customers to discontinue use and discard any recalled product. OCD customers with questions should be contact Customer Technical Services at 1-800-421-3311.

Device

VITROS Chemistry Products COCM Reagent
  • Model / Serial
    Product Code: 6801995; Lot numbers: 1) 1525-09-2754 Exp Date: 1 Nov 2013, 2) 1525-10-2091 Exp Date: 1 March 2014, 3) 1525-10-3062; Exp Date: 1 April 2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US nationwide (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico), Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
  • Product Description
    VITROS Chemistry Products COCM Reagent
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA