Events

Recall of Device Recall ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent

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
    71843
  • Event Risk Class
    Class 2
  • Event Number
    Z-2739-2015
  • Event Initiated Date
    2015-07-27
  • Event Date Posted
    2015-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139201
  • 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
    Acid, folic, radioimmunoassay - Product Code CGN
  • Reason
    Low red blood cell control recoveries and low results for red blood cell patient samples when using the advia centaur systems folate assay.
  • Action
    An Urgent Medical Device Recall (UMDR) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 27, 2015 to be delivered to customers on July 28, 2015. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 27, 2015. These notices inform the customer to discontinue use of ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent kit lots 54942, 56230 and 70673 and dispose of the remaining inventory per local regulations. The ADVIA Centaur Systems Folate red blood cell sample and control negative bias is minimal in the lower range of the assay and is more pronounced with increasing folate concentrations. The negative bias could lead to a misclassification of a patient as folate deficient. Siemens does not recommend a look back of previously tested patients. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Recall and completed the required actions.

Device

Device Recall ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent
  • Model / Serial
    Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
  • Product Description
    ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. || Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA