Events

Recall of Device Recall ADVIA Centaur Calibrator 30

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
    78645
  • Event Risk Class
    Class 2
  • Event Number
    Z-0515-2018
  • Event Initiated Date
    2017-06-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160060
  • 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
    Radioimmunoassay, estradiol - Product Code CHP
  • Reason
    Siemens healthcare diagnostics has confirmed a negative bias for advia centaur enhanced estradiol (ee2) on the advia centaur, advia centaur xp and advia centaur xpt systems when calibrating with calibrator 30 kit lots ending in 21 (c3021) as compared to calibrator 30 kit lots ending in 20 (c3020).
  • Action
    An Urgent Medical Device Recall letter dated June 7, 2017 was distributed to all customers in the United States and an Urgent Field Safety Notice was distributed to all customers outside the United States who have received ADVIA Centaur Systems Calibrator 30 kit lot ending in 21(C3021). These letters instruct customers who operate the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems to discontinue use of C3021 . The letters inform customers that Calibrator 30 kit lots ending in 20 (C3020) and 23 (C3023) are not impacted and can be used. The letters inform customers who operate ADVIA Centaur CP systems to continue using their inventory of C3021, as they are not impacted by this issue. All affected domestic customers were sent a hard copy of the Urgent Medical Device Recall via Federal Express. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall letter.

Device

Device Recall ADVIA Centaur Calibrator 30
  • Model / Serial
    Lot Numbers: 00387A21, 16673A21, 36243A21;  00388A21, 15448A21, 51211A21;  20640A21; 51024A21.  Expiration Date: 2018-03-08
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US and OUS.
  • Product Description
    ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. || Siemens Material Number (SMN): 10379810, 10379811, 10697756.
  • 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