Events

Safety Alert for ARCHITECT SHBG Reagents

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

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
    2017-04-24
  • Event Date Posted
    2017-04-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170424b.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: abbott architect shbg reagents medical device manufacturer, abbott, has issued a medical device safety alert concerning its architect shbg reagents. [list numbers (lot numbers): 8k26-20 (01916e000, 00316f000, 01816g000, 00916i000, 07316i000, 00916l000] and 8k26‐25 (01816e000, 00216f000, 01716g000, 00816i000, 07216i000) ]. the manufacturer has identified that architect shbg results generated with the potassium edta specimen tube type may demonstrate a negative shift relative to results generated with serum. shbg dimer destabilization in edta could result in low shbg measurements by immunoassay. there is a potential for falsely decreased architect shbg results to be generated when using the architect shbg assay with the potassium edta specimen tube type. internal studies have determined use of the potassium edta specimen tube type may result in a decrease in shbg concentration values of greater than 20% when compared with serum collected in serum tubes. the shift was observed across the full analytical range of the assay. as a result, an increase in free androgen index / free testosterone index calculations of up to 30% may also be observed when using potassium edta specimen tubes. affected users are instructed to discontinue use of the potassium edta specimen tube type with the architect shbg assay according to their laboratory procedures. the issue should be reviewed with their medical director to determine if a review of results previously generated using the potassium edta specimen tube type is necessary. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 april 2017.

Device

ARCHITECT SHBG Reagents
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott ARCHITECT SHBG Reagents
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • 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