Events

Recall of Device Recall Dimension Vista B2 Microglobulin Flex Reagent Cartridge

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
    73080
  • Event Risk Class
    Class 2
  • Event Number
    Z-1030-2016
  • Event Initiated Date
    2015-11-03
  • Event Date Posted
    2016-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143028
  • 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
    System, test, beta-2-microglobulin immunological - Product Code JZG
  • Reason
    Siemens healthcare diagnostics has confirmed an increase in the rate of abnormal assay errors and calibration failures with the dimension vista b2mic flex reagent cartridge: dimension vista system flex reagent cartridge and urine stabilizer b2mic. in the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other markers of renal injury.
  • Action
    Siemens sent an Urgent Medical Device Recall dated November 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and discard your remaining inventory of the affected product. Indicate your replacement product needs on the attached Field Correction Effectiveness Check Form and return. For questions call Siemens Customer Care Center- Technical Solutions at 800-441-9250 or your local Siemens technical support representative.

Device

Device Recall Dimension Vista B2 Microglobulin Flex Reagent Cartridge
  • Model / Serial
    Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and US in the state of CA.
  • Product Description
    Dimension Vista System || B2 Microglobulin Flex reagent cartridge and urine stabilizer || Catalog #K7024 SMN: 10445889 Lot #15246MA || Product Usage: || The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA