Events

Recall of Device Recall Dropper Plus PointofCare Urinalysis Dipstick Control kit

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

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
    80179
  • Event Risk Class
    Class 3
  • Event Number
    Z-2257-2018
  • Event Initiated Date
    2017-12-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164785
  • 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
    Urinalysis controls (assayed and unassayed) - Product Code JJW
  • Reason
    The kits contained an incorrect lot of dropper plus level 1 vials.
  • Action
    Communication with their only customer for this recall was via e-mail and phone. Upon notification by the customer the following activities were initiated: All lots of the Dropper Plus product in inventory were 100% inspected. The customer was ask to return all of the kits to Quantimetrix. For further questions please call (310) 536-0006.

Device

Device Recall Dropper Plus PointofCare Urinalysis Dipstick Control kit
  • Model / Serial
    Lot 44450E
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of : Kansas
  • Product Description
    Dropper Plus Point-of-Care Urinalysis Dipstick Control kit || The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
  • Manufacturer
    Quantimetrix Corporation

Manufacturer

Quantimetrix Corporation
  • Manufacturer Address
    Quantimetrix Corporation, 2005 Manhattan Beach Blvd, Redondo Beach CA 90278-1205
  • Manufacturer Parent Company (2017)
    Quantimetrix Corporation
  • Source
    USFDA