Events

Recall of Device Recall Phadia 1000 Instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Phadia US 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
    78752
  • Event Risk Class
    Class 2
  • Event Number
    Z-0387-2018
  • Event Initiated Date
    2017-07-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160281
  • 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
    System, test, radioallergosorbent (rast) immunological - Product Code DHB
  • Reason
    The "retry" command does not function properly which could cause a shortage of wash and rinse solution and affect assay performance and test results.
  • Action
    The firm sent letters with a return response form to customers. The firm instructed customers to immediately choose the "stop" command if presented with the 7-101 Liquid Sensor Error. Results from the assay should not be approved. A revision of the current software will have a mandatory installation soon.

Device

Device Recall Phadia 1000 Instrument
  • Model / Serial
    All versions of the instrument
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Phadia 1000 Instrument, Article Number 12-3800-01.
  • Manufacturer
    Phadia US Inc

Manufacturer

Phadia US Inc
  • Manufacturer Address
    Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
  • Manufacturer Parent Company (2017)
    Fsii Sweden Holdings I Ab
  • Source
    USFDA