Events

Recall of Device Recall VITROS Chemistry Products CDM PROM

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
    68840
  • Event Risk Class
    Class 2
  • Event Number
    Z-2214-2014
  • Event Initiated Date
    2014-07-15
  • Event Date Posted
    2014-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128837
  • 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, multi-analyte mixture - Product Code JIX
  • Reason
    Inability to calibrate or use vitros nh3 dt slides, gen 59 with vitros chemistry products dt calibrator kit, lot 44 when cdm prom 0168 or 0169 is installed on vitros dt60/dt60 ii chemistry systems.
  • Action
    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification letter dated July 15, 2014,by Federal Express overnight to all affected customers. All US end-user consignees who had been shipped VITROS NH3 DT slides, GEN 59, Product Code 1532589 were informed of the issue. Customers were instructed to: a) use VITROS DT NH3 slides, GEN 59 with Calibration Data Module, Rev. 0168 or 0169 with VITROS DT Calibrator, Lot 42 if available; or b) If VITROS DT Calibrator, lot 42 is not available, the user is instructed to request CDM, Rev. 0170 to be used with VITROS NH3 DT slides, GEN 59 and VITROS DT Calibrator, Lot 44. Customers were instructed to forward this notice if the product was further distributed outside of their facility. OCD has manufactured a new CDM, Rev. 170, containing the necessary data/calibration mathematics for VITROS DT Calibrator, Lot 44 to be used to calibrate VITROS NH3 DT slides, GEN 59. Customers with questions were instructed to call Customers Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

Device

Device Recall VITROS Chemistry Products CDM PROM
  • Model / Serial
    Lots 0168 and 0169
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MA, TX, KY, IL, MS, OH and Puerto Rico; Internationally to: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • Product Description
    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY
  • 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