Events

Safety Alert for ADVIA Chemistry Systems A1c_3 calibrator

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

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
    2014-08-22
  • Event Date Posted
    2014-08-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140822.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: siemens advia chemistry systems a1c_3 calibrator medical device manufacturer, siemens healthcare diagnostics, has issued a medical device safety alert concerning its advia chemistry systems a1c_3 calibrator [catalogue no.: 10491408 & lot no.: 3hd044; 3ld068]. the manufacturer is conducting a recall of the advia chemistry systems a1c_3 calibrator lots 3hd044 and 3ld068. the manufacturer has confirmed that the advia chemistry systems a1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (hb)a1c samples when using a1c_3 calibrator lots 3hd044 and 3ld068. depending on quality control limits, this issue may not have been detected. note: the percent bias range is a percentage of the hba1c result. it is not absolute hba1c units. according to the manufacturer, a percent bias of up to +11% may be considered clinically significant at clinically relevant hba1c ranges between ~5.5% and 8.0%, and may result in the modification of the therapy for hyperglycemia. the modification of hyperglycemic therapy can increase the risk of occurrence of hypoglycemia, which may be observed through personal glucose monitoring and/or patient symptoms. affected users are advised to discontinue use of and discard the affected products. the manufacturer is not recommending a general look back for the laboratory for previously generated results when using these calibrator lots. the manufacturer is also providing a physician letter with retesting guidance for physicians. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 aug 2014.

Device

ADVIA Chemistry Systems A1c_3 calibrator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Siemens ADVIA Chemistry Systems A1c_3 calibrator
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics