Events

Safety Alert for ARCHITECT Intact PTH Assay

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

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
    2014-02-14
  • Event Date Posted
    2014-02-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140214.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 laboratories architect intact pth assay medical device manufacturer, abbott laboratories, has issued a field safety notice concerning certain lots of architect intact pth assay with list numbers: reagents (8k25-20, 8k25-25, 8k25-27), calibrators (8k25-01) and controls (8k25-10). the manufacturer has confirmed that a performance shift in the architect intact pth assay has the potential to generate falsely elevated results on patient samples. results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. the issue may also impact established architect intact pth reference ranges. abbott architect intact pth controls do not detect the shift. all current reagent, calibrator, and control inventory is impacted. falsely elevated patient results are generated when using the architect intact pth assay. the manufacturer advises users of the followings: to discontinue use of, and destroy, any remaining inventory of affected products; to continue intact pth testing at the laboratory, users should identify an alternate method for testing patient samples; and the field safety notice should be reviewed with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary. for non-enterobacteriaceae (quality control purpose), the mic shift over the time can be greater than +1 dilution when compared to the mics initially obtained at the time of the release. for enterobacteriaceae, the over-estimation of mic can change the category result of isolates having mic equal or close to the breakpoint. according to the manufacturer, this performance issue leading to this over-estimation of mic can be detected using the quality control as recommended in the etest package insert. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 february 2014.

Device

ARCHITECT Intact PTH Assay
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Laboratories ARCHITECT Intact PTH Assay
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 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