Events

Recall of VITROS Chemistry Products Calibrator Kit 9

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
    72289
  • Event Risk Class
    Class 3
  • Event Number
    Z-0202-2016
  • Event Date Posted
    2015-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140484
  • 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
    The firm is conducting a product correction due to an increase in u90-382 or 6lu condition codes (wash errors) when using vitros calibrator kit 9, lot 0954.
  • Action
    Customer letter (Ref. CL2015-191) was sent on 9/28/2015 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) and /or ORTHO PLUS e-Communications to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected calibrator lot, discard the remaining inventory of the affected lot and recalibrate VITROS DGXN and PHYT Slides using Cal Kit 9 with an alternative lot of calibrator kit 9 upon availability. Distributor letter (Ref. DL2015-191) was sent on 9/28/2015 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 the required actions. The foreign affiliates were notified via e-mail on 9/28/2015.

Device

VITROS Chemistry Products Calibrator Kit 9
  • Model / Serial
    Lot 0954, exp. date 31-May-2016
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela
  • Product Description
    VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA