FDA: Don’t Buy These ‘Uncertified’ COVID-19 Test Kits, Face Masks, Blood Pressure Monitors

• Despite the need to stop the rise of COVID-19 cases in the country, the Philippine Food and Drug Administration (FDA) warns healthcare professionals and the general public against buying ‘uncertified’ medical equipment and devices in the market.

  Since the start of October 2021, the agency has identified at least four brands and products that have not gone through their evaluation process and have not been certified for public use. These products include:

  Circle Health Pod Testing Kit

  The product claims to be a portable testing kit for COVID-19, Influenza, and STDs with an accuracy value of up to 96% for sensitivity and 99.% for specificity. Upon verification, this product does not have a corresponding Special Certification, and the agency cannot assure its safety and quality.

  Japan Quality Face Mask

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  While the box contains the FDA logo, the agency says the product remains unnotified and it has not gone through the evaluation process of the FDA. 

  The agency also reiterates that under Circular No. 2013-030 or ‘Guidelines on the Use of the FDA Logo and Name in Promotional, Advertisement, Sponsorship, Marketing or Commercial Materials,’ “no person, establishment or organization, shall use the FDA logo, the words ‘Food and Drug Administration’ or ‘Philippine FDA,’ the initials ‘FDA’, or any imitation of such words, initials, or logo in print and other forms of broadcast media, including the internet, in connection with any health product, merchandise, impersonation, solicitation, or commercial activity in  a manner that convey that such use is approval, endorsement, or authorization by the FDA unless with written permission from the agency.”

  Click here for a list of FDA-approved face mask brands.

  Aneroid sphygmomanometers

  More commonly known as blood pressure monitors, aneroid sphygmomanometers are instruments that measure indirect arterial blood pressure. These are often used in hospitals and clinics because of its high accuracy. However, the FDA identified some brands that remain unregistered with their agency. These include:

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  “Additionally, with the issuance of FDA Circular No. 2020-010 entitled ‘Prohibition of Online Selling of Unregistered/Unnotified Medical Devices,’ the FDA prohibits the online selling of medical devices and supplies without their corresponding authorization,” the FDA said in their advisory. 

  First Aid Disposable Vinyl Gloves 

  The FDA has verified that the product is not notified and has no corresponding Product Notification Certificate. According to the FDA, since it has not gone through their evaluation process, the agency cannot assure its quality and safety. 

  “Moreover, all concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued,” said the FDA in its advisory. 

  If you are unsure about the product you are purchasing, you can always check first if it has been registered and notified by the FDA. Use the search feature on their website at www.fda.gov.ph or you may look for the FDA notification number on the product labelled as DVR-xxx, MDR-xxx, or CMDN-xxx. 

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  If you suspect that a seller is unlicensed or is an unauthorized distributor of a health product, you may report it to the FDA via email at report@fda.gov.ph or directly through their eReport online facility www.fda.gov.ph/ereport. 

  Counterfeit medicine used as treatment for COVID-19 is also being sold online. FDA shows how to spot the fakes here.

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FDA: Don’t Buy These ‘Uncertified’ COVID-19 Test Kits, Face Masks, Blood Pressure Monitors
Source: Progress Pinas