FDA Advisory 2017-271
Public Health Warning Against the Purchase and Use of Unregistered Medical Device Product One Step Cassette Style HIV 1+2 Rapid Screen Test (whole blood) from Online Sellers and other Unauthorized Distributors
The Food and Drug Administration (FDA) advises the public against the purchase and use of unregistered medical device product One Step Cassette Style HIV 1+2 Rapid Screen Test (whole blood):
FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration.
Pursuant to the provisions of Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded are prohibited.
The abovementioned products did not undergo the evaluation process of the FDA. Thus, the agency cannot guarantee its quality and safety.
In this regard, the public is hereby advised not to purchase the above-mentioned violative product and to be vigilant against the medical device products that are not registered with the FDA.
All concerned establishments and/or entities are warned not to advertise, sell or distribute the said product until such have been issued by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.
All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.