FDA Recalls March 12-18, 2022

Food & Beverage Recalls

Cavendish Farms Issues Allergy Alert on Undeclared Wheat in Original Hash Brown Patties

Cavendish Farms Corporation of Dieppe, New Brunswick, Canada, is recalling 441 cases of its 42.3 oz packages of Original Hash Brown Patties because they may contain undeclared wheat. People who have allergies to wheat or celiac disease run the risk of serious allergic reaction if they consume this product.

The recalled Original Hash Brown Patties were sold in Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, and Rhode Island in retail supermarkets that are part of the Wakefern Food Corp. cooperative which include ShopRite, Price Rite Marketplace, The Fresh Grocer and Fairway Market. The stores have removed the product from shelves.

The product comes in a 42.3 oz package with the UPC code 0 56210 34217 1 and a best before date of 2024 FE 01 stamped on the side.

Medical Device Recalls

ACON Laboratories Issues a Recall of Non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U.S. Market

SAN DIEGO, CA, January 9, 2022 – ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).” ACON Laboratories is not importing the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” into the U.S. as it is only authorized for sale in Europe and other markets, under the CE mark. This press release serves as public announcement that this CE marked product is being recalled from the U.S. market. The “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” cannot be legally imported, distributed, or used in the U.S. market as it has not been approved, cleared, or authorized by the FDA. The “Flowflex COVID-19 Antigen Home Test” cannot be legally imported, distributed, or used in the European market as it is not CE marked. These two products have been authorized by the U.S. FDA and registered under CE Mark authorities separately under different product registration requirements, and therefore:

• This recall shall have no impact on the distribution and use of the CE marked “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” in Europe and other markets outside of the U.S.
• This recall shall have no impact on the distribution and use of the FDA authorized “Flowflex COVID-19 Antigen Home Test” in the United States.