Events

Recall of Device Recall ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2pack

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
    67021
  • Event Risk Class
    Class 2
  • Event Number
    Z-0929-2014
  • Event Initiated Date
    2013-12-18
  • Event Date Posted
    2014-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124531
  • 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
    Enzyme immunoassay, diphenylhydantoin - Product Code DIP
  • Reason
    Advia centaur¿ systems phenytoin calibrator n, lots cn58 and higher, change in recovery observed with the advia centaur systems phenytoin assay compared to recoveries using previous calibrator n lots.
  • Action
    Siemens Healthcare Diagnostics Customer Notification notice was sent to affected Siemens Healthcare Diagnostic customers in the United States on December 18, 2013.. The notifications inform customers that Siemens Healthcare Diagnostics received customer feedback regarding the performance of the ADVIA Centara¿ Systems Phenytoin assay, indicating that the assay was recovering higher relative to the performance of other assays in proficiency studies. Siemens internal investigation confirmed the positive bias for Calibrator N lot CN 57 in the ADVIA Centaur Systems Phenytoin assay. This lot has expired and is no longer in use. Expected performance has been restored starting with Calibrator N lot CN58. Siemens is notifying customers that have received Calibrator N lots CN58 and higher that there will be a change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. Siemens is providing data to inform customers of the expected difference between Calibrator lots CN58 and higher versus prior Calibrator N lots. Customers were instructed to retain the letter with their laboratory records, and forward to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customers Care Center or their local Siemens technical support representative. For questions regarding this recall call 508-668-5000.

Device

Device Recall ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2pack
  • Model / Serial
    Lot # Expiry Date  19002A58 06/09/2014; 19088A58 06/09/2014; 21376A58 06/09/2014; 25657A59 09/29/2014; 26830A59 09/29/2014; 28447A59 09/29/2014.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay.
  • Product Description
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack || SMN 10311391 || For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
  • 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