FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests

Original from: MedtechDive

The Woodside Acquisitions recall report is part of the spate of regulatory actions related to the sale of tests that are unauthorized for use in the U.S. Numerous COVID-19 tests that are not authorized for distribution in the U.S. have made it into the country, and the FDA has issued several recalls for those products.

Woodside Acquisitions’ recall of two COVID-19 tests fit the pattern. One of the products recalled is the Joysbio SARS-CoV-2 Antigen Rapid Test Kit. A product made by Joysbio, a Chinese test provider, has a CE mark and is sold in countries including the U.K. However, Joysbio isn't among the companies with emergency use authorization (EUA).

Despite the test lacking an EUA, Woodside Acquisitions distributed 17,000 Joysbio kits in Alabama and Georgia. It contacted the distributors last month to ask them to return the tests. If a distributor had passed the kits on to another company, Woodside Acquisitions asked it to forward the recall information to all affected customer accounts.

The company sent emails about the other test on the same day. That test is called “Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test” in the FDA’s notice, a generic name that makes it hard to determine the manufacturer of the product. Woodside Acquisitions is recalling 34,240 units of the test from distributors in Alabama and Georgia. 

The FDA shared details of the two Woodside Acquisitions recalled products days after flagging problems with 6,177 Accula SARS-CoV-2 Tests. Mesa Biotech, now part of Thermo Fisher Scientific, is recalling the PCR tests because contamination at the manufacturing facility has caused affected lots to have an increased risk of giving false positive results.

Last month, Mesa Biotech asked customers to stop using test kits from the identified lots and discard or return remaining inventory. The FDA followed up with a notice categorizing the recall as a Class I event earlier this month.

Source: FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests