Alerta De Seguridad para BD Pharmingen, Horizon and Phosflow

Safety alert

2017-03-09

2017-03-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170309a.html

Medical device safety alert: bd pharmingen, horizon and phosflow medical device manufacturer, bd, has issued a medical device safety alert concerning its products: bd pharmingen [product format: alexa fluor 700, apc-cy 7, apc-h7, pe-cy 5], bd horizon [product format: apc-r700, buv661, bv605, bv650, bv711, bv786, pe-cf594] and bd phosflow [product format: alexa fluor 700]. the manufacturer has observed an increase in the number of complaints of low or no signal, or lot-to-lot variability in signal for single vial reagents with fluorophores. in some cases, users observed vial-to-vial variability in signal within the same lot. based on internal investigations, the manufacturer has identified specific lots of the above product formats, shipped between 16 may 2016 and 10 february 2017, that are being recalled. the manufacturer has launched a thorough investigation to identify root cause for the sporadic degradation of the reagents. at this time, all data suggest that a significant change in the lighting conditions at an alternate warehouse location is the primary contributor of the low to no signal in the product. based on the investigation, the current storage requirement on the product labeling, “store undiluted at 4°c and protected from prolonged exposure to light,” is sufficient to protect the product from degradation. according to the manufacturer, the potential degradation of product may result in a false identification of cell populations and/or aberrant staining patterns. the manufacturer advises users to take the following actions: either discard any remaining inventory and request a replacement or perform quality control using biological cells per their standard protocol on each vial of reagent just prior to use to confirm that the reagent is still performing as intended; and review any data that may have been generated from the affected product list. 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 9 march 2017.