Events

Recall of Device Recall ADVIA Chemistry A1c_3 Calibrators

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
    65868
  • Event Risk Class
    Class 2
  • Event Number
    Z-2135-2013
  • Event Initiated Date
    2013-07-30
  • Event Date Posted
    2013-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120612
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Reason
    Siemens confirmed that the advia¿ chemistry systems hba1c method exhibits a positive bias of up to 12% for patient and cap survey samples due to over-recovery when using a1c_3 calibrator lots 1md014, 1bd063, and 2gd014. the established ranges of cap survey samples gh2-04, gh2-05 and gh2-06 and ifcc sample recoveries use ¿ 7% from the established mean as their acceptance criteria. this is the criterion that was used during testing to confirm the customer complaints. depending upon quality control limits this issue may not have been detected.
  • Action
    Siemens sent an Urgent Medical Device Correction letter dated July 30, 2013, to all affected customers via FedEx (for US consignees). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and discard any of the affected reagent kit lots. Customers werealso requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative for questions. For questions regarding this recall call 914-524-2955.

Device

Device Recall ADVIA Chemistry A1c_3 Calibrators
  • Model / Serial
    Lots 1MD014 (exp. date 5/01/2013), 1BD063 (exp. 5/01/2013), 2GD014 (exp. 10/01/2014)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hungary, Indonesia, Italy, Kazakhstan, Lithuania, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, South Africa, South Korea, Thailand, Turkey, Uruguay, Vatican City, and Vietnam.
  • Product Description
    ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators || Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. || For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA¿ Chemistry systems.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

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