Recall of Device Recall MedTest DX Control Reconstitution Fluid

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MedtestDx, Inc..

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
    71993
  • Event Risk Class
    Class 2
  • Event Number
    Z-2768-2015
  • Event Initiated Date
    2015-05-15
  • Event Date Posted
    2015-09-15
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-05-23
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Reason
    Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. an under-fill of the vials was found ranging as low as 4.63 ml. when used to reconstitute hnc/hec, control values were shown to be out of range running on the high end.
  • Action
    On 5/15/2015, MedTest DX Field Correction Notice notifications were sent to the affected customers via electronic mail and US mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to MedTest Technical Service Department at 1-800-757-5313.

Device

  • Model / Serial
    Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    MedTest DX Control Reconstitution Fluid || Kit configuration: 20 x 5 ml. || Bottle: 5 ml amber glass || Cap: 18 mm white seal plug seal rubber || HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MedtestDx, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Manufacturer Parent Company (2017)
  • Source
    USFDA