Events

Recall of PHADIA 100 SYSTEM - ALLERGENS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHADIA AB.

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
    66405
  • Event Risk Class
    III
  • Event Initiated Date
    2018-01-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Somagen diagnostics along with thermofisher scientific would like to notify you of an urgent recall and backorder of immunocap allergen c5 ampicilloyl product code 14-4450-01 and immunocap allergen c6 amoxicilloyl product code 14-4451-01. an internal monitoring stability study has indicated that stability specifications have not been met and were in fact half the intended expiry date of 12 months. there is a possibility that samples with a low positive concentration may be incorrectly reported as negative. any reported test results below the assay limit of qualification (loq) should be disregarded as these results may be invalid. no complaints or injuries to patients have been reported.

Device

PHADIA 100 SYSTEM - ALLERGENS
  • Model / Serial
    Model Catalog: 14-4451-01 (Lot serial: 991D7); Model Catalog: 14-4451-01 (Lot serial: 991DC); Model Catalog: 14-4451-01 (Lot serial: 991DB); Model Catalog: 14-4451-01 (Lot serial: 991D8); Model Catalog: 14-4451-01 (Lot serial: 991D9); Model Catalog: 14-4450-01 (Lot serial: 990DT); Model Catalog: 14-4450-01 (Lot serial: 990DS); Model Catalog: 14-4450-01 (Lot serial: 990DU); Model Catalog: 14-4450-01 (Lot serial: 990DV); Model Catalog: 14-4451-01 (Lot serial: 991DA); Model Catalog: 14-4450-01 (Lot serial: 990DX); Model Catalog: 14-4450-01 (Lot serial: 990DY); Model Catalog: 14-4450-01 (Lot serial: 990DZ); Model Catalog: 14-4450-01 (Lot serial: 990DW)
  • Product Description
    ImmunoCAP Allergen c6 Amoxicilloyl;ImmunoCAP Allergen c5 Ampicilloyl
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB