Events

Recall of Device Recall MicroScan Synergies Plus Negative Panels

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Microscan.

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
    49114
  • Event Risk Class
    Class 2
  • Event Number
    Z-0541-2009
  • Event Initiated Date
    2008-07-31
  • Event Date Posted
    2009-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72796
  • 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
    Falsely lowered imipenem mics may result, leading to major errors in results.
  • Action
    Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance.

Device

Device Recall MicroScan Synergies Plus Negative Panels
  • Model / Serial
    All lots
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    MicroScan Synergies Plus Negative Panels, 20 panels per box || Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. || Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101
  • Manufacturer
    Siemens Microscan

Manufacturer

Siemens Microscan
  • Manufacturer Address
    Siemens Microscan, 1584 Enterprise Blvd, West Sacramento CA 95691-3422
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA