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Public Alert No. 048/2022 – Warning Against Counterfeit Covid-19 Antigen Rapid Test Kits

December 14, 2022,

The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers of a safety communication by Health Canada following the discovery of counterfeit BTNX Incorporated COVID-19 rapid antigen test kits in Ontario, Canada. The counterfeit test kits were sold online in 25-pack boxes by a distributor called Healthful Plus without the required licence.

The packaging of the counterfeit kits resembles the authentic (licensed) BTNX Inc. products in colour and typeface and uses the BTNX Inc. device identifier “COV-19C25”, but also has several key differences. The counterfeit kits:

  • are labelled as manufactured by “Health Advance Inc.” instead of BTNX Inc.;
  • lists Health Advance as an “Official Canadian Distributor”; and
  • includes the text “Health Canada Approved”. Claims of endorsement by government authorities, such as Health Canada, are not permitted.

Genuine COVID-19 Antigen test helps detect certain proteins in the virus. Rapid antigen tests are designed to tell in a few minutes whether someone is infectious or not. It is recommended as a high performing test for individuals with symptoms, high-risk populations, and healthcare or casual workers.

Counterfeit health products are imitations of authentic products. The safety and effectiveness of these counterfeit test kits have not been assessed.

The genuine manufacturer BTNX Inc. has confirmed that the devices were counterfeit. 

The table below shows the difference between the counterfeit and authentic COVID-19 rapid antigen test kit;

Image Counterfeit BTNX test kit (25-pack) Counterfeit BTNX test kit (25-pack) Image Authentic BTNX test kit (25-pack) Authentic BTNX test kit (25-pack)

Counterfeit box (top)

Health Advance name and phone number along with text “Official Canadian Distributor” and unauthorized text “Health Canada Approved” appear on box.

 

Authentic box (top)

Authentic boxes are sealed with a clear sticker with blue lettering that says “QC APPROVED”.

Counterfeit box (side)

Health Advance name and phone number appear on box.

 

Authentic box (side)

BTNX Inc. name, address and symbol appear on box.

 

Counterfeit kits – three open boxes

Each box has varying contents, including varying test cassettes and assay buffers.

 

Authentic kit – open box

Shown here: test cassettes, tube stand, assay buffer, swabs, procedure card and package insert.

Note, assay buffer may come in bottles (shown here) or 25 single-use vials (not shown here).

Not shown here: extraction tubes and nozzle filters

Counterfeit kits – cassette pouch found in some kits

Expiry date and lot number may not match the box. Pouches are not green.

Authentic kit – box and cassette pouch (back)

Lot number and expiry date on cassette pouch should match the lot number and expiry date on the box. Lot numbers start with the letter “I”.

NAFDAC advice wholesalers, distributors, pharmacies and consumers to ensure that products are obtained from authentic and reliable sources. Increased vigilance is hereby encouraged within the supply chain to avoid the importation, distribution, sale or use of the counterfeit COVID-19 rapid antigen test kits and to prevent the administration of the product to unsuspecting patient by healthcare providers. The products’ authenticity and physical condition should be carefully checked. 

Anybody in possession of the counterfeit product should immediately discontinue sale or use and submit stock to the nearest NAFDAC office.

Healthcare providers and consumers are encouraged to report any suspicion of counterfeit drug product to NAFDAC on 0800-162-3322 or email: sf.alert@nafdac.gov.ng, report adverse events experienced with the use of the counterfeit product to the nearest NAFDAC office, via pharmacovigilance@nafdac.gov.ng, E-reporting platforms available at www.nafdac.gov.ng or via the Med- safety application for download on android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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