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Fact Check-FDA did not recall all COVID-19 PCR tests

Users on social media are interpreting a screenshot of a U.S. Food and Drug Administration (FDA) recall of one company’s COVID-19 test to mean that all PCR tests have never worked. FDA officials confirmed the recall does not extend to all PCR tests authorized for use by the agency, and that the posts link to the FDA’s recall of just one company’s test.

On July 23, 2021, social media users began sharing posts regarding the integrity of all PCR tests without additional context. Posts read, in part, "The FDA announced today that the CDC PCR test for COVID-19 has failed its full review," and end with “THIS IS THE SINGLE MOST HORRIFIC CRIME AGAINST HUMANITY SINCE THE DAWN OF MANKIND.” Examples can be seen here and here .

On June 6, 2021, the FDA published a Class 1 medical device recall for the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, which produces a result faster than a PCR test that must be analyzed in a laboratory. The recall notice, visible here - says the device distributed between November 2, 2020 and March 22, 2021 by the Innova Medical Group presented “a risk of false results”, thereby not meeting performance standards. According to the FDA recall notice, the test presents "false-negative results (that) may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause patient harm including serious illness and death".

A further FDA announcement about the Innova recall can be seen here .

Concerns regarding this device’s safety are valid; the level one recall is the most urgent and severe type of recall published by the FDA.

However, there is no evidence to support claims that the FDA has recalled all PCR tests and therefore that this recall is proof that the coronavirus pandemic was staged or cases falsified. The Innova test is not a PCR test, and multiple other PCR tests remain on the market.

A current list of medical products recalled (including dates) by the FDA is viewable here . According to the 2021 medical device recall list, the Innova Medical Device Group COVID-19 diagnostic test is one of only three testing devices recalled due to inaccurate results.

An FDA spokesperson confirmed to Reuters via email that "the FDA has authorized more than 300 tests and sample collection kits to diagnose COVID-19, many of which are PCR tests". A list of the multiple other PCR tests currently authorized by the FDA to diagnose COVID-19 is visible here (type PCR in the search bar).

Previous Reuters Fact-Checks about PCR misinformation can be seen here , here and here .

VERDICT

Partly false. While posts feature the screenshot of one FDA recall of a rapid COVID-19 test, multiple other PCR tests for SARS-CoV-2 remain on the market.

This article was produced by the Reuters Fact Check team. Read more about our fact-checking work here .

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