Events

Recall of Immulite 2000 Rubella Quantitative IgG, Immulite 2500 Rubella IgG

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
    53675
  • Event Risk Class
    Class 2
  • Event Number
    Z-1033-2010
  • Event Initiated Date
    2009-10-21
  • Event Date Posted
    2010-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86308
  • 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
    Rubella IgG - Product Code LFX
  • Reason
    The recall was initiated because siemens healthcare diagnostics has identified there is the potential for patient results to be biased low (-0.3 sample to cutoff [s/co] ratio units) due to incompatibility of the toxoplasma igm kits with this particular lot of igg/igm sample diluent. all available lots of the immulite 2000/2500 toxoplasma igm kits (l2ktm/l5ktm) are incompatible with diluent lot 150.
  • Action
    The customer notification was initiated on 10/22/2009 with the firm forwarding an Urgent Field Safety notice with attached Field Correction Effectiveness Check form to the affected consignees informing them of the issue and the products affected. The consignees were informed that Siemens is initiating the Field Correction (FC) to prevent IMMULITE 2000/2500 Toxoplasma IgM from being run with Diluent lot 150. The consignees were instructed in the interim, until replacement kit lots of RUB IgG and CMV IgG are received, your laboratory can continue using Rubella IgG, CMV IgG, or Toxoplasma IgM as long as Diluent Lot 150 is not loaded on the analyzer when running Toxoplasma IgM. Diluent Lot 150 can be used with RUB IgG and CMV IgG. Once the replacements lots are received, any unopened kit lots listed in the above table MUST BE RETURNED to Siemens per instructions that will accompany a separate Fed Ex Call Tag that will explain the proper return of the affected product. The consignees were also instructed to complete the attached Field Correction Effectiveness Check form and fax to the firm's technical solutions center. Additional questions should be directed to the firm at 973-927-2828.

Device

Immulite 2000 Rubella Quantitative IgG, Immulite 2500 Rubella IgG

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc., 5700 W 96th St, Los Angeles CA 90045-5544
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA