Events

Recall of Device Recall Dimension Lipase 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
    79468
  • Event Risk Class
    Class 2
  • Event Number
    Z-1796-2018
  • Event Initiated Date
    2017-12-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162393
  • 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
    Calibration failure - confirmed a positive bias with lipl lot fb8109 when compared to other dimension lipl lots. lot fb8109 is not meeting siemens internal specifications for lot-to-lot limits.
  • Action
    Customers are instructed to: - Discontinue use of Dimension LIPL Assay lot FB8109. ¿- Recalibrate with an alternate lot of Dimension LIPL Assay. ¿- Review their inventory of this lot to determine their laboratory¿fs no-charge replacement needs. ¿- Review the UMDR/UFSN letter with their Medical Director. ¿- Complete and return the Field Correction Effectiveness Check Form attached to the UMDR/UFSN letter within 30 days. - If they have received any complaints of illness or adverse events associated with lot FB8109, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative

Device

Device Recall Dimension Lipase Flex Reagent Cartridge

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