Events

Safety Alert for Test Cells for Red Cell Antibody Screening

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by DiaMed.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-02-14
  • Event Date Posted
    2017-02-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170214.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: diamed test cells for red cell antibody screening medical device manufacturer, diamed, has issued a field safety notice concerning its test cells for red cell antibody screening. the product names (catalogue numbers) of the affected devices are as below: id-dia (diego) positive (004134); id-diacell sf (003640); id-diacell pool (003630 / 003631); id-diacell abo/i-ii (003610); id-diacell abo/i-ii-iii (003618); id-diascreen i-ii-iii-iv-vp-vip (004316); id-diacell i-ii (003613); id-diapanel (004114); id-diacell i-ii-iii (004310); id-diascreen i-ii-iii-iv (004311); id-diacell i-ii-iii asia (003614); id-diascreen prophylax (004330); id-diapanel plus 6 (004414); id-diacell i-ii (003613vj); id-diapanel (1-11) (004114vj ); id-dia positiv (004134vj); id-diacell i-ii-iii (004310vj) the manufacturer has identified unexpected reactions primarily on eluates and qc samples but also with some patient samples when using the above mentioned products. this phenomenon is observed randomly between batches, and also within single batches. according to the manufacturer, a risk assessment has been done, and the conclusion is that this unexpected result requires further confirmation testing before a final transfusion decision is made. negative results can be reliably accepted as negative. the manufacturer advises affected users of the following:- in case of doubtful reactions, re-test with a new kit. if the results remain in doubt, send the sample to a reference laboratory and if an urgent transfusion is required, perform a crossmatch. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 february 2017.

Device

Test Cells for Red Cell Antibody Screening
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: DiaMed Test Cells for Red Cell Antibody Screening
  • Manufacturer
    DiaMed

Manufacturer

DiaMed