Events

Recall Or Safety Alert for D-10 hemoglobin testing system with accessories

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Bio-Rad Laboratories, Inc. (Bio-Rad plant in France), USA.

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
    Recall / Safety alert
  • Event Number
    ИМ-7.5112/1002
  • Date
    2014-05-03
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. 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 Belarus.
  • Extra notes in the data
  • Reason
    In rare cases, the software of the d-10 system may produce an additional result, duplicating the result of the comparison of the previous and next samples. the duplicate is easily detected when sorting the identification numbers of the samples examined during the day, in this case the serial numbers of the samples are duplicated. the manufacturer recommends that users carefully study the reports or printed chromatograms obtained during the day, in order to identify duplicates. such duplication may lead to inconsistent sampling results.

Device

D-10 hemoglobin testing system with accessories

Manufacturer

Bio-Rad Laboratories, Inc. (Bio-Rad plant in France), USA