Events

Recall of Sentinel MULTIGENT Ammonia Ultra Reagent

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

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
    72311
  • Event Risk Class
    Class 2
  • Event Number
    Z-0164-2016
  • Event Initiated Date
    2015-09-22
  • Event Date Posted
    2015-10-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140563
  • 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
    Enzymatic method, ammonia - Product Code JIF
  • Reason
    Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
  • Action
    Sentinel Urgent Field Safety Notice issued on 9/22/15 by Abbott to customers, including their US customers. Actions to be Taken 1. Immediately discontinue use of lot 50083Y600 and destroy any remaining inventory. 2. Order a replacement Ammonia Ultra reagent lot. 3. Follow your individual laboratory protocol regarding reviewing previously reported patient results. 4. Please retain this communication for future reference. If you have forwarded any MULTIGENT Ammonia Ultra reagent lot 50083Y600 to another laboratory, please provide a copy of this letter to them. Contacts If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers should contact Customer Service at 1-877-4 ABBOTT.

Device

Sentinel MULTIGENT Ammonia Ultra Reagent
  • Model / Serial
    Lot 50083Y600, expiration date 31 Jul 2016.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
  • Manufacturer
    Sentinel CH SpA

Manufacturer

Sentinel CH SpA
  • Manufacturer Address
    Sentinel CH SpA, Via Robert Koch 2, Milano Italy
  • Manufacturer Parent Company (2017)
    Sentinel Ch. Spa
  • Source
    USFDA