Events

Recall of Advia Chemistry Systems Calibrator

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
    75487
  • Event Risk Class
    Class 2
  • Event Number
    Z-0589-2017
  • Event Initiated Date
    2016-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150481
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Reason
    Siemens has confirmed that the dbil_2 assigned calibrator values (acv) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement.
  • Action
    Siemens issued an Urgent Medical Device Correction in the US and an Urgent Field Safety Notice Outside the US beginning on October 6, 2016. Customers were notified of the issue and instructed to use the reassigned DBIL_2 calibrator value for Chemistry Calibrator Lot Numbers 680726, 680726A, 680726B, 680726C and 680726D. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days by faxing to the Customer Care Center at 312-275-7795. For questions regarding this recall call 914-631-8000.

Device

Advia Chemistry Systems Calibrator
  • Model / Serial
    Device Listing # D033650 Model# SMN# 10312279 Lot Numbers: 680726, 680726A, 680726B, 680726C, 680726D
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Internationally to Canada, Mexico, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, Cyprus, Denmark, Egypt, Ecuador, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Russian Fed. Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, Vatican City and Vietnam
  • Product Description
    Advia Chemistry Calibrator || For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)
  • 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