Events

Recall of PHADIA 250 SYSTEM - INSTRUMENT REAGENTS

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
    24248
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-06
  • 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
    There have been reports of instrument malfunctions for phadia 250 due to deformed bottles in the below mentioned products and lots. the deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent thus generating insufficient dilution of patient samples. the deformation is described as a flange or brim located on the inside lower part of the vial opening. the instrument malfunction due to deformed bottles could cause erroneous test results mainly false positive with regard to all elia assays and mainly falsely increased test results for immunocap total ige and immunocap igg4/igg assays. the frequency of this bottle defect is very low and not every defective bottle will cause the error. an instrument malfunction caused by deformed bottles will generate the instrument error message "3-145 right arm liquid detection below lower limit with target 2". it is important that you review your records for the above mentioned error message.

Device

PHADIA 250 SYSTEM - INSTRUMENT REAGENTS
  • Model / Serial
    Model Catalog: 83-1023-01 (Lot serial: JM3Y); Model Catalog: 83-1023-01 (Lot serial: JS0B); Model Catalog: 83-1023-01 (Lot serial: JP87); Model Catalog: 83-1023-01 (Lot serial: JK5N); Model Catalog: 83-1023-01 (Lot serial: JU9C)
  • Product Description
    EliA Sample Diluent
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB