Events

Recall of Device Recall Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL)

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
    69149
  • Event Risk Class
    Class 2
  • Event Number
    Z-0024-2015
  • Event Initiated Date
    2014-08-28
  • Event Date Posted
    2014-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129748
  • 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
    Calibrator, secondary - Product Code JIT
  • Reason
    Siemens healthcare diagnostics has determined that dimension vista® mass ckmb isoenzyme calibrator (mmb cal) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. siemens has observed drift from 3% to 12% at mmb concentrations across the assay range. depending on quality control limits, this drift may not have been d.
  • Action
    An Urgent Medical Device Recall notice, dated August 2014, was provided to all Dimension Vista¿ MMB CAL customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers. Customers were instructed to discard lots 3JD045, 4BD064, 4CD012, and 4DD065, and recalibrate with lot 4FD073.

Device

Device Recall Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL)
  • Model / Serial
    lot 3JD045, exp. 2014-10-01; lot 4BD064, exp. 2015-02-01; lot 4CD012, exp. 2015-03-01; and lot 4DD065, exp. 2015-05-01.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwided distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, Slovenia, South Korea, Spain, and Switzerland.
  • Product Description
    Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.
  • 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