According to a Reuters Fact Check, that's not the case at all. In fact, the recall only applies to one company's PCR test, the Innova SARS-CoV-2 Antigen Rapid 

21/03/2022 · FDA issued two Class 1 Device Recalls, the most serious type of recall, for the Celltrion DiaTrust™ COVID-19 Ag Rapid Test, Reference Number CT-P60 D-2 02. FDA initially authorized this test on April 16, for use at the point-of-care (POC) such as health clinics and congregate settings.

FDA Advisory No.2021-1896 || Recall of COVID-19 Test Kits with Low Results of Performance Validation Conducted by the Research Institute of Tropical Medicine ( 

North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or approved by the U.S. Food and Drug Administration (FDA) for distribution or use in the United States. While

10/06/  · Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results, The FDA has identified this as a Class I recall,

09/02/2022 · In a January 9 press release, ACON Laboratories revealed they had issued a recall of the Flow flex SARS-CoV-2 Antigen Rapid Test (Self-Testing), which had been distributed throughout the US,

15/06/2022 · 618 Ridgewood Ave. Holly Hill FL 32117-3604. Manufacturer Reason. for Recall. Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA. FDA Determined. Cause 2.

Master Lot Number Final Kit Lot Number Expiration Date Retailer/Distributor 21047‑4 21047‑4 February 28, 2022 Department of Defense; Institut 21047‑5 21047‑5 February 28, 2022 Department of Defense 21089‑1 21089‑1 March 31, 2022 Department of Defense; Institut

for Recall: Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. FDA Determined Cause 2: Other: Action: On April 1, 2022, the firm notified distributors of the issue via letter, following up with meetings with each distributor on April 5, 2022 and emails on April 6, 2022.

CovClear COVID-19 Rapid Antigen and ImmunoPass COVID-19 Neutralizing Antibody Rapid tests have been recalled by Empowered Diagnostics, 

SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA.

The FDA labeled the recall a Class I event. The agency wrote that the products have the possibility of false positive or negative test results, misinterpretation of results and serious adverse health consequences, including death. The company initiated the fourth recall of its rapid COVID-19 tests in recent weeks, which the FDA designated

June 9, 2022, Update: The FDA updated this recall classification notice to remove Woodside Acquisitions Inc from the device use section of the notice. This firm's name does not appe the label for the Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) and to clarify that these tests were not authorized, cleared, or approved by

05/05/2022 · The Food and Drug Administration labeled another COVID-19 rapid antigen test as a Class I event, assigning the highest risk category to SML Distribution’s withdrawal of 209,450 unauthorized products. SML began contacting its customers by phone in March and went on to email a recall notice later that month.

The Food and Drug Administration announced a Class 1 recall of the E25Bio COVID-19 Direct Antigen Response Test. E25Bio is recalling its 

26/04/  · for Recall: Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S. FDA Determined Cause 2: No Marketing Application: Action: On 4/26/ , Lepu Medical issued an "Urgent: Medical Device Recall Notification" to all affected consignees. In addition, to informing consignees about the recall

The latest recall again relates to the distribution of kits. This time, as many as 311,100 Point of Care DiaTrust COVID-19 Ag Rapid Tests have been sent to users that lack the certification needed to use them under the terms of the emergency use authorization. The FDA set out why that is a problem in its Class I recall notice.

20/08/  · But in its recall announcement, the FDA described Innova’s recall of its SARS-CoV-2 Antigen Rapid Test as a “ Class 1 recall ” and gave the stern warning, “Use of these devices may cause serious injuries or death.”,

Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are

The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. More than 2 million tests made by the company that were

The FDA has issued a Class I recall warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use.

The Class 1 device recall for Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) is due to it being "distributed without 

The maker of a certain brand of COVID-19 tests has issued a recall because the tests are not authorized, cleared or approved by the U.S. 

The Food and Drug Administration published a Class I recall report for two COVID-19 testing products that covers the removal of more than 

Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only The FDA has identified this as a Class I recall, the most serious type of recall. Use