Events

Recall of Device Recall MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34

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
    61610
  • Event Risk Class
    Class 2
  • Event Number
    Z-1498-2012
  • Event Initiated Date
    2011-06-16
  • Event Date Posted
    2012-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108536
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Reason
    Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.
  • Action
    Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.

Device

Device Recall MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo T...
  • Model / Serial
    lot code 2011-07-22.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Turkey, Poland, and Great Britain.
  • Product Description
    MicroScan Dried Overnight Gram Negative Panels; || Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404. || Siemens Healthcare Diagnostics, || West Sacramento, CA.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA