Events

Safety Alert for Clinical Chemistry Alkaline Phosphatase Reagent

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott 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
    2011-08-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110830.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
    Product recall: abbott diagnostics clinical chemistry alkaline phosphatase reagent abbott diagnostics (abbott) has issued an urgent product recall on clinical chemistry alkaline phosphatase reagent lots 71628un10, 62474un10, and 08145un11, due to particulate matter in some reagent cartridges, which has been identified as a cladosporium fungal species. according to abbott, the fungus does not represent a hazard, but appears to generate visible clumps within the reagent cartridge, and may cause discoloration over time. abbott supplemented that they have not received reports of inaccurate alkaline phosphatase results due to this issue, nor has internal testing demonstrated any impact to results; however, having confirmed the error codes on calibration and sample runs, internal data suggests a rare (0.00636%) potential for inaccurate results to exist. the supplier suggests that, if you are using or have inventory of clinical chemistry alkaline phosphatase (ln 7d55-21 lot 71628un10, or ln 7d55-31 lot 62474un10 and/or lot 08145un11), you should discontinue use and destroy any remaining inventory of those lots in accordance with your institution’s policies and procedures. according to the local supplier, the affected products have been distributed in laboratories in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Clinical Chemistry Alkaline Phosphatase Reagent
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [30 Aug 2011] Abbott Diagnostic Clinical Chemistry Alkaline Phosphatase Reagent
  • Manufacturer
    Abbott Diagnostics

Manufacturer

Abbott 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