Events

Safety Alert for Biotestcell I8, Biotestcell I11 and Biotestcell I11E

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

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
    2014-06-20
  • Event Date Posted
    2014-06-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140620a.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: bio-rad biotestcell i8, biotestcell i11 and biotestcell i11e medical device manufacturer, bio-rad, has issued a field safety notice (fsn) concerning biotestcell i8 (code no. 816 020), biotestcell i11 (code no. 816 021) and biotestcell i11e (code no. 816 051). the affected lot number is 2422011-00. due to subsequent exchange of one donor cell in the cell panel of the products mentioned above, an incorrect version of the worksheet was used for packaging. this worksheet contains incorrect information for cell i7. with this incorrect worksheet an identification of anti-jkb, -s and -s antibodies is not possible. misinterpretations do not occur. using the affected reagents as control reagent will lead to a discrepant result misleadingly indicating a problem with the tested reagent (e.G. seraclone anti-jkb, anti-s, anti-s). the manufacturer advises users not to use worksheets included in the packages of the lots mentioned above. a fsn with corrected worksheets containing correct donor information for cell i7 was issued to alert users. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 jun 2014.

Device

Biotestcell I8, Biotestcell I11 and Biotestcell I11E
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bio-Rad Biotestcell I8, Biotestcell I11 and Biotestcell I11E
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad