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
    120285
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-15
  • 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
    Immunocap allergen fx20 food contains a mix of f4 (wheat) f5 (rye) f6 (barley) f9 (rice). due to a production nonconformity the above mentioned lots of immunocap allergen fx20 food contain traces of oat (f7) allergen. the described nonconformity could cause false positive test results with regard to sensitization to fx20 allergens for samples that are positive for oat allergen and negative for wheat rye barley and rice allergens. however this is an unlikely event because of the extensive cross-reactivity between different cereal allergens and the low probability of monosensitization to oat allergen in patients. therefore it is unlikely that presence of oat allergen in immunocap allergen fx20 should result in incorrect test results for patient samples.

Device

PHADIA 100 SYSTEM - ALLERGENS
  • Model / Serial
    Model Catalog: 14-4853-01 (Lot serial: AAS0G); Model Catalog: 14-4853-01 (Lot serial: AAS0D); Model Catalog: 14-4853-01 (Lot serial: AAS0E); Model Catalog: 14-4853-01 (Lot serial: AASG3); Model Catalog: 14-4853-01 (Lot serial: AASG2); Model Catalog: 14-4853-01 (Lot serial: AASG1); Model Catalog: 14-4853-01 (Lot serial: AAS0H); Model Catalog: 14-4853-01 (Lot serial: AAS0F)
  • Product Description
    IMMUNOCAP ALLERGEN FX20
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB