Events

Recall of Siemens Chemistry Calibrator used with the ADVIA Chemistry Direct Bilirubin 2 Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics.

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
    66396
  • Event Risk Class
    Class 2
  • Event Number
    Z-0365-2014
  • Event Date Posted
    2013-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122248
  • 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
    Diazo colorimetry, bilirubin - Product Code CIG
  • Reason
    Siemens healthcare diagnostics is conducting a field correction for siemens chemistry calibrator lots 090445b and 090445c on the advia 1200, 1650, 1800, and 2400 chemistry systems. the system specific values (ssvs) for the direct bilirubin assay (dbil_2) have been reassigned for these lots. siemens has determined that the dbil_2 ssvs currently assigned to these lots may cause an average shift of.
  • Action
    Siemens Healthcare Diagnostics sent an Urgent Medical Device Correction Letters dated September 24, 2013 and Response Forms to the US consignees via FedEx. Urgent Field Safety Notices were also distributed to customers outside the US. Customers are instructed to use the reassigned System Specific Values for the affected lots listed in the letter. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within thirty (30) days. The questionnaire is to be faxed to the Technical Solutions Center at 302-631-7597. On September 30, 2013, Siemens sent a revised customer notifications to correct the Part Number.

Device

Siemens Chemistry Calibrator used with the ADVIA Chemistry Direct Bilirubin 2 Reagent
  • Model / Serial
    Lots 090445B (exp. 07/2014) and 090445C (exp. 10/2014)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Guadeloupe, Guatemala, Great Britain, Greece, Korea, Indonesia, Israel, Italy, Kazakhstan, Latvia, Liechstenstein, Lithuania, Luxembourg, Macedonia, Martinique, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovenia, Slovakia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, and Vietnam.
  • Product Description
    Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD || Product usage: Usage: || DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Manufacturer Address
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA