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
    69872
  • Event Risk Class
    Class 2
  • Event Number
    Z-0947-2015
  • Event Initiated Date
    2014-11-20
  • Event Date Posted
    2015-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131895
  • 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
    During an investigation of instrument logs it was determined that in specific circumstances involving multiple steps, a rack sequencing error may occur. this will result in a mismatch between the sample id and the test result reported for all subsequent sample racks in that run.
  • Action
    ThermoFisher sent an Urgent Medical Device Product Correction letter to all affected customers. The firm will inform customers of the specific sequence of errors and operator actions that can trigger the event via letter and phone, and will request that they do not respond to the Barcode Read Error and let the sample with the error eject normally from the instrument and be rerun after the barcode read error has been resolved. The firm will issue a mandatory Phadia 1000 Instrument Software (ISW) update that will correct the issue and make efforts to install it within 45 days from date of availability. Customers were asked to return the written response form via fax to: 1-888-243-5214 Attention: Customer Support, Phadia 1000 ISW Product Correction Response; EMAIL: Compliance-us.idd@thermofisher.com Email Subject Line: Phadia 1000 ISW Product Correction Response. Customers with questions were instructed to contact Phadia US Technical Support at 800-346-4364, option 2. For questions regarding this recall call269-492-1957.

Device

Device Recall Phadia 1000 Instrument
  • Model / Serial
    Part Number 12-3800-01
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
  • Product Description
    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
  • 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