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:
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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 [email protected].
Dissemination of the information to all concerned is requested.