Events

Safety Alert for SD Bioline HIV-1/2 v3.0

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Standard 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
    2012-03-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120307c.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
    Field safety notice: sd bioline hiv-1/2 v3.0 the world health organization (who) issued a field safety notice on 16 nov 2011 concerning sd bioline hiv-1/2 v3.0 manufactured by standard diagnostics, inc. according to the notice, some lots of the device showed unacceptably high rate (around 50%) of invalid test results. subsequently, who issued an information update on 6 jan 2012 stating that the devices giving invalid test results show a substantial red background in the test window where results are read. this blurs the visibility of the test lines and therefore makes correct interpretation of the test result impossible. this means that no test result can be given, rendering the test invalid. standard diagnostics has conducted a root cause analysis as recommended by the who and determined the problem was due to defective sample pad and non-standard shape of nozzle leading to excessive assay diluents migration which would blur the test window where results are read. according to who, there is no evidence that would warrant the retesting of individuals for whom an unambiguous, valid positive or negative test result using this test, has been obtained. a positive hiv test result given to an individual should always be confirmed with a second and/or third test different from the initial screening test. persons whose test results were invalid (non-readable) would need to be retested as their serostatus remain undetermined. who recommended that national authorities should discontinue use of all affected lots of the product and quarantining also the unaffected lots until further testing can determine their performance. further, who also recommended any pending procurement of the product should be cancelled, and no new procurement initiated until further notice. who will re-inspect the manufacturing site and an information update will be issued afterwards. according to the local supplier, affected lots have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

SD Bioline HIV-1/2 v3.0
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SD Bioline HIV-1/2 v3.0
  • Manufacturer
    Standard Diagnostics

Manufacturer

Standard Diagnostics
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • 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
    DH