Events

Safety Alert for ARCHITECT STAT High Sensitive Troponin-I Assay

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
    2016-05-03
  • Event Date Posted
    2016-05-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160503.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 stat high sensitive troponin-i assay medical device manufacturer, abbott, has issued a medical device safety alert concerning its architect stat high sensitive troponin-i assay. the manufacturer is informing affected users of a product recall and reduced expiration dating for select architect stat high sensitive troponin-i reagent lots. predictive quality assurance monitoring of architect stat high sensitive troponin-i reagent lots was initiated following the field action that occurred in january (fa21jan2016). as a result, the manufacturer has identified a potential for increased calibration failures prior to the expiration date. according to the manufacturer, there is a potential for delay in results due to calibration errors and failure to calibrate. nonetheless, there is no impact to generated patient results. manufacturer will continue to monitor performance of all on-market lots. until root cause is determined and corrective actions are implemented, new reagent lots will have a proactively shortened expiration date of 4 months from date of manufacture. the expiration date will require adjustments to the laboratory inventory and order management practices. affected users are instructed either: to destroy any remaining inventory of affected lots once an alternate reagent lot is available, or to adjust the expiration date of the affected lots 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 3 may 2016.

Device

ARCHITECT STAT High Sensitive Troponin-I Assay
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott ARCHITECT STAT High Sensitive Troponin-I Assay
  • 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