Events

Recall of Device Recall PROTrac II Tacrolimus ELISA kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diasorin 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
    70773
  • Event Risk Class
    Class 2
  • Event Number
    Z-1464-2015
  • Event Initiated Date
    2015-03-16
  • Event Date Posted
    2015-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134645
  • 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
    Enzyme immunoassay, tracrolimus - Product Code MLM
  • Reason
    Instability in the pro-trac ii tacrolimus elisa kit which may cause falsely elevated patient results.
  • Action
    DiaSorin sent a Customer Notification Letter" to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete and return the confirmation form to the manufacturer. For questions contact DiaSorin Inc. Product Support at 1-800-328-1482.

Device

Device Recall PROTrac II Tacrolimus ELISA kit
  • Model / Serial
    131716, 131716A, 131716B, 131716C, 131716D, 131716E,  131717.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
  • Product Description
    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. || Product Usage: || The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
  • Manufacturer
    Diasorin Inc.

Manufacturer

Diasorin Inc.
  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    USFDA