Events

Recall of Device Recall SmartCycler

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

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
    32756
  • Event Risk Class
    Class 2
  • Event Number
    Z-1378-05
  • Event Initiated Date
    2005-07-22
  • Event Date Posted
    2005-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40773
  • 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
    Prosthesis, Orthodontic - Product Code NSR
  • Reason
    A problem in the software has the potential to be associated with the incorrect reporting of sample results.
  • Action
    On 7/22/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the corrective action.

Device

Device Recall SmartCycler
  • Model / Serial
    All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
  • Product Classification
    Dental Devices
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
  • Product Description
    SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
  • Manufacturer
    Cepheid

Manufacturer

Cepheid
  • Manufacturer Address
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA