Flex Flow COVID Test: Understanding the Recall and Risks

The ongoing COVID-19 pandemic has seen numerous developments in testing technologies, including antigen tests that can detect the presence of SARS-CoV-2 antibodies in individuals. Recently, ACON Laboratories, Inc., the manufacturer of the 'Flowflex COVID-19 Antigen Home Test,' announced a recall of their products due to concerns over unauthorized distribution and use outside of approved markets.

Recall Impact

The recall affects two distinct products: the FDA authorized 'Flowflex COVID-19 Antigen Home Test' in the United States and the CE marked 'Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)' in Europe and other non-US markets. This means that the recalled tests cannot be legally imported, distributed, or used in either the US or European market, as they are not authorized by the respective regulatory bodies.

Risks Associated with Unauthorized Tests

The manufacturer emphasizes the importance of using only FDA-approved or CE-marked products to avoid any risks associated with inaccurate test results. Unapproved tests can lead to false negative or false positive results, which may have serious consequences in public health management and individual patient care.

Public Health Response

In response to the recall, public health officials in at least one New York county issued a notice to residents, urging them to differentiate between the recalled test and the one cleared for emergency use. The manufacturer has also released a side-by-side comparison of the two products to help consumers make informed decisions.

Manufacturer Statement

ACON Laboratories has stated that they have not received any reports of adverse events related to either test and have issued the recall 'out of an abundance of caution.' The company highlights the potential risks associated with using unauthorized tests, emphasizing that these products may lead to inaccurate results, including false negative or false positive test results.

The recall of 'Flowflex' antigen tests serves as a reminder of the importance of ensuring that COVID-19 testing products are authorized and approved for use in specific markets. As we continue to navigate the pandemic, it is crucial that individuals and healthcare professionals prioritize the use of FDA-approved or CE-marked tests to minimize risks and ensure accurate results.

Flex flow covid test