Events

Recall of Device Recall Dimension Vista beta2Microglobulin Flex Reagent Cartridge (B2MIC)

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
    71831
  • Event Risk Class
    Class 2
  • Event Number
    Z-2450-2015
  • Event Initiated Date
    2015-07-23
  • Event Date Posted
    2015-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139174
  • 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
    Customers are receiving a high number of abnormal assay errors or are not able to calibrate b2mic when using flex reagent cartridge b2mic various lots. in failure mode, there is the potential for falsely depressed beta2-microglobulin results on the dimension vista system due to assay reagent contamination.
  • Action
    Siemens sent an Urgent Medical Device Correction letter dated July 2015 to all affected customers. The letter identified the affected product, problem, risk to health, and actions to be taken by customers. For questions contact your Customer Care Center - Technical Solutions at 1-800-441-9250 or your local Siemens technical support representative.

Device

Device Recall Dimension Vista beta2Microglobulin Flex Reagent Cartridge (B2MIC)
  • Model / Serial
    Lot Number:15037MA; ExpDate: 2016-07-14 Lot # 15175MA; ExpDate: 2015-11-17; Lot # 15204MA; Expdate: 2017-01-13;  Lot #15246MA; expdate: 2017-02-26 Lot # 15267MA; expdate: 2017-02-26
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI
  • Product Description
    Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); || Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-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