Events

Recall of VITROS Chemistry Products Calibrator Kit 24

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
    60794
  • Event Risk Class
    Class 2
  • Event Number
    Z-0971-2012
  • Event Initiated Date
    2011-10-27
  • Event Date Posted
    2012-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106485
  • 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
    Calibrator, secondary - Product Code JIT
  • Reason
    Ortho clinical diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using vitros¿ chemistry products calibrator kit 24 and vitros¿ chemistry products malb reagent.
  • Action
    All consignees were sent "Important Product Correction Notification" communications (dated 10/27/11) beginning on 10/27/11 informing them of the issue, and instructing them to discontinue use of their remaining inventory of VITROS¿ Chemistry Products Calibrator Kit 24, VITROS¿ Chemistry Products mALB reagent, and VITROS¿ Chemistry Products mALB Performance Verifiers. For questions, please contact OCD's Customer Technical Services at 1-800-421-3311.

Device

VITROS Chemistry Products Calibrator Kit 24
  • Model / Serial
    Kit Lot 2430 (exp. 11/16/11), Kit Lot 2440 (exp. 01/08/12), Kit Lot 2450 (03/09/12), Kit Lot 2471 (exp. 7/14/12)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • Product Description
    VITROS¿ Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of albumin in urine. Ortho-Clinical Diagnostics Inc.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA