Events

Recall of Device Recall ImmunoCAP Allergen Ri206

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
    60513
  • Event Risk Class
    Class 3
  • Event Number
    Z-1055-2012
  • Event Initiated Date
    2012-01-03
  • Event Date Posted
    2012-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105658
  • 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
    Reagent, specific, analyte - Product Code MVU
  • Reason
    The firm found this lot of immunocap allergen ri206, american cockroach does not contain sufficient levels of some cockroach allergens e.G. tropomyosin. approximately 2% of the positive samples have a risk to fall below the limit of quantization (o .1 kua/l).
  • Action
    ThermoFisher sent an URGENT RECALL NOTIFICATION letter dated December 22, 2011, to all affected consignees. The letter identifed the product, the problem, and the action to be taken by the conignee. Consignees were recommended to cease testing on the affected lot of product and, if so desired, substitute with ImmunoCAP Allergen i6, German Cockroach, until ImmunoCAP Allergen Ri206 was in stock. For any questions regarding this notification, contact Technical Support at 800.346.4364, option 2.

Device

Device Recall ImmunoCAP Allergen Ri206
  • Model / Serial
    Article number 14-5274-10, Lot number BDZ0P
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide to include: MN, VA, NC, MO, SC, TX, MA, MI, FL, IL, PA, MD, UT, CO, GA, CA,
  • Product Description
    ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana || It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen IgE in human serum or plasma.
  • 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