Safety Alert for Alere SD BIOLINE HIV Ag/Ab Combo

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

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
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • 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: alere sd bioline hiv ag/ab combo medical device manufacturer, alere, has issued a medical device safety alert concerning its sd bioline hiv ag/ab combo [product codes: 03fk30, 03fk35; lot numbers: 03bda003a, 03bda004a, 03bda005a, 03bda006a, 03bda006b, 03bdb001a, 03bdb001b, 03bdb001c, 03bdb002a]. the manufacturer has received two performance complaints of sd nioline hiv ag/ab combo in february 2017 from kyrgyzstan. they investigated the complaints and confirmed that the affected lots did not meet the performance claim for analytical sensitivity of p24 antigen (claimed detection limit in the package insert: 2iu/ml, however the affected lots detect a concentration of 16 iu/ml. according to the manufacturer, when performing as expected, the p24 component of the assay may enable the detection of the infection about 7 days before the antibody results become positive. if a patient is in very early diagnostic window period, the lower p24 sensitivity of the affected lots may reduce the detection period by one or two days, with the possibility of a false negative result. if a false negative result occurs, it is possible that treatment of a patient that is hiv positive could be delayed and further transmission of the infection to sexual partners or through blood transfusion could occur. the users are advised to take the following actions: examine their inventory immediately to determine if they have product on hand subject to this action. if so, quarantine such product(s). remove the products subject to this voluntary recall, and dispose or destroy the product. for patients of which negative results on p24 antigen were obtained, conduct confirmatory assays. according to the local supplier, the affected products are distributed in hong kong and product recall is on-going. there was no adverse event reported. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 may 2017.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Alere SD BIOLINE HIV Ag/Ab Combo
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source