Events

Safety Alert for PATHFAST CK-MB AND PATHFAST NTproBNP REAGENTS

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by N/A.

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
  • Event Number
    2018-206
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/514569-fda-advisory-no-2018-206
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2018-206 voluntary recall of the pathfast ck-mb and pathfast ntprobnp reagents  all are hereby advised by the food and drug administration (fda) on the voluntary recall of pathfast ck-mb with lrd/cdrrhr_exemp-2015-6374 and pathfast ntprobnp with lrd/cdrrhr_exemp-2015-6372 distributed by global medical solutions, inc., with business address at 3/f 14 economia st., bagumbayan, quezon city with the following information: product name catalogue no. lot no. pathfast ck-mb pf1031-k 0769 pathfast ntprobnp                pf1061-k 0768 pathfast ntprobnp                pf1061-k 0769 the cited medical device was voluntarily recalled by global medical solutions, inc. due to the several reagent cartridges had tiny pinhole on the aluminum seal at the well position of alkaline phosphatase labelled antibody reagent which was generated during the filling process. in case the reagent leaked through the pinhole, the appropriate result may not be obtained. the above recalled medical device products might results in deviation of accuracy of the data if reagent leakage occurs through the pinhole.    distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots.  any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested.      attachments: fda advisory no. 2018-206.Pdf.

Device

PATHFAST CK-MB AND PATHFAST NTproBNP REAGENTS
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP