Events

Recall of Device Recall ImmunoCAP" Allergen c5, Ampicilloyl

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
    79444
  • Event Risk Class
    Class 2
  • Event Number
    Z-1312-2018
  • Event Initiated Date
    2017-12-18
  • 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=162338
  • 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 stability specifications of immunocap allergen c5, ampicilloyl were not met.
  • Action
    Customers are being asked to please stop using all current product, and scrap any unused products. ¿ Please disregard any reported test result below the assay Limit of Quantification (LoQ 0.1 kUA/l) from the lots, as these results may not be valid. Please note that assay results above the Limit of Quantification, will only be affected by giving a lower result than the real value. ¿ Please fill in the Recall Letter Acknowledgement Form provided, including the table in the response form to obtain credit, and return the signed response by e-mail or fax.

Device

Device Recall ImmunoCAP" Allergen c5, Ampicilloyl
  • Model / Serial
    Lots  990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). || ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
  • 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