Events

Recall of Device Recall ADVIA Chemistry Triglyceride_2 concentrated

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    73635
  • Event Risk Class
    Class 2
  • Event Number
    Z-1670-2016
  • Event Initiated Date
    2016-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144641
  • 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
    Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
  • Reason
    Siemens healthcare diagnostics has confirmed the advia chemistry triglyceride concentrated reagent (trig_c) does not meet instructions for use (ifu) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.
  • Action
    Siemens mailed an Urgent Field Safety Notice, dated March 2016, to customers confirming the ADVIA Triglyceride concentrated reagent (TRIG_c) does not meet Instructions for Use (IFU) linearity claim at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932. Siemens asked customers to discontinue use of and discard kits from the two referenced lots, complete and return the Field Correction Effectiveness Check attached to the letter within 30 days. Customers were to review their inventory to determine their laboratory 's replacement needs. Customers are asked to retain the letter for their records and forward a copy to anyone that received the product. Customers may contact Siemens Customers Service or their local technical support.

Device

Device Recall ADVIA Chemistry Triglyceride_2 concentrated
  • Model / Serial
    Kit lots 348297 & 359932.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of CA, TN, UT, OK, FL, MI, MN, NY, CT, NC, KS, TX, CO, WA, NM, and OR; and, the countries of Austria, Australia, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany. Great Britain, Italy, Latvia, Netherland, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, India, New Zealand, Thailand, Turkey, and Russian Fed.
  • Product Description
    ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. || For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA