Events

Recall of Device Recall Siemens Healthcare Diagnostices Inc. MIcroScan MICroSTREP plus Type 1 B1027201 panels.

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
    64699
  • Event Risk Class
    Class 2
  • Event Number
    Z-1272-2013
  • Event Initiated Date
    2013-03-06
  • Event Date Posted
    2013-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116809
  • 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
    Panels, test, susceptibility, antimicrobial - Product Code LTT
  • Reason
    Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with a. agalactiae affecting multiple antimicrobial agents on microscan microbiology systems.
  • Action
    Siemens Healthcare sent a Urgent Field Safety Notification letter dated March 6, 2013, to all affected customers of MicroScan MICroSTREP plus type 1, who process panels in a Walk Away System. The letter identified the product the problem and the action needed to be taken by the customer. As stated in our product Instructions for Use, test results should be interpreted in conjunction with the patients medical history, clinical presentation and other findings. We recommend discussing the content of this letter with your laboratory director regarding the need to review previous test results, conduct patient follow-up, and/or repeat testing for testing conducted in the last twelve months. Confirmation of receipt of this letter is required. Attached you will find a form indicating you have received and understood the information. We would greatly appreciate your assistance in notifying us that you have received the information by taking a moment to complete and return the form below. If you require further information or assistance, please contact your local Siemens Healthcare Diagnostics Representative. Please forward this notification to anyone to whom you may have distributed this product. We apologize for the inconvenience that this situation has caused. For further questions please call 1-800-677-7226 Option 1 (USA/Canada) Thank you for your patience and continued support.

Device

Device Recall Siemens Healthcare Diagnostices Inc. MIcroScan MICroSTREP plus Type 1 B1027201 pan...
  • Model / Serial
    All lots within expiration: Lot numbers: 2013-02-24 2013-03-05 2013-03-06 2013-04-03 2013-04-04 2013-04-19 2013-05-01 2013-05-10 2013-05-18 2013-05-21 2013-06-07 2013-06-18 2013-06-25 2013-07-27 2013-08-10 2013-08-23 2013-09-11 2013-09-14 2013-09-28 2013-10-02 2013-11-01 2013-11-02 2013-11-15 2013-11-29 2013-12-07 2013-12-12 2013-12-17 2014-01-04 2014-01-09 2014-01-15 2014-02-01 2014-02-13.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including Puerto Rico.
  • Product Description
    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. || .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
  • 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