Events

Recall of Device Recall ADVIA Chemistry XPT

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
    74830
  • Event Risk Class
    Class 2
  • Event Number
    Z-2704-2016
  • Event Initiated Date
    2016-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148550
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Reason
    Siemens identified an issue with the ratio equation provided on the advia chemistry xpt system software test definition (tdef) version 1.0 disks (smn: 11127343 and 11222123). this issue affects only the advia chemistry hemoglobin a1c_3 automated pretreatment (a1c_3) results when hba1c values are reported in international federation of clinical chemistry (ifcc) equivalent units (hba1cr). the ratio equation used to calculate advia chemistry hemoglobin a1c_3 automated pretreatment (a1c_3) results in ifcc units contains an error. the error results in falsely depressed hba1cr results.
  • Action
    Siemens sent an Urgent Field Safety Notice dated July 20, 2016, to all affected customers via Fed Ex and the Urgent Field Safety Notice (CHSW16-02 July 2016) was e-mailed to regional countries for implementation Outside US (OUS). Customers have been advised to stop reporting results and call Siemens immediately to schedule service. The file with the typographical error is located on ADVIA Chemistry XPT Test Definition (TDef) disk. -- Field service personnel were sent a support bulletin describing the issue and instructing them how to correct the equation. Service engineers have been instructed to remove all version 1.0 TDef disks from customer sites regardless of whether they run the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment assay and report in IFCC units. Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative.

Device

Device Recall ADVIA Chemistry XPT
  • Model / Serial
    CA1275002940294 and lower
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US to MA, NY, MI, IL, TX, CO, AZ, CA, WA and Foreign distribution to the following countries: Australia, Austria, Bahrain, Brazil, China, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Malaysia, Netherlands, New Zealand, Norway, Portugal, Portugal, Republic Korea, Singapore, Slovakia, Spain, Sweden, Turkey, United Kingdom, and Vietnam.
  • Product Description
    ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). || The ADVIA Chemistry XPT System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour
  • 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