Events

Recall of Device Recall Dimension LIP 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
    55571
  • Event Risk Class
    Class 2
  • Event Number
    Z-0588-2011
  • Event Initiated Date
    2010-03-10
  • Event Date Posted
    2010-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91152
  • 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
    Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
  • Reason
    Open well instability: after calibration, qc shifts high (out of range) after the flex well is hydrated. shifts of up to 20% have been observed in both qc and patient samplesas soon as two hours post hydration.
  • Action
    Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.

Device

Device Recall Dimension LIP Flex Reagent Cartridge

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA