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Recent Recall a Reminder to Check Which COVID-19 Tests Your Lab Can Use

by | May 11, 2022 | Articles, News, Open Content

Celltrion’s recall was labeled by the FDA as Class I, due to the kits possibly being distributed to non-CLIA certified users.

A recent recall of point-of-care (POC) COVID-19 tests serves as a reminder that’s it’s always a good idea to check to make sure your lab is authorized to use the tests it provides to patients. The tests in question—Celltrion USA’s Celltrion DiaTrust COVID-19 Ag Rapid Tests—were recalled starting April 4 as they may have been distributed to unauthorized users. The recall, which affected as many as 311,100 test kits, was classified as a Class I—the most serious kind—by the FDA on April 28, according to a statement from the agency.

The POC kits, which are used to detect the SARS-CoV-2 virus that causes COVID-19 in patients based on a nasopharyngeal swab sample, are only authorized for use by CLIA-certified labs that have a corresponding CLIA Certificate Number, according to the FDA. Unauthorized users may not have the training or qualifications to properly perform the tests, increasing the chance of false results and potentially putting the public at risk, the FDA said in its April 28 statement on the recall.

Celltrion first let affected customers know in early April via email, asking that the kits not be used and to return them to the distributor. Those who may have been affected include anyone tested with the kits, those who used the tests at non-CLIA certified facilities, and distributors of the tests. The affected Celltrion DiaTrust COVID-19 Ag Rapid Test kits have distribution dates from December 2021 to February 2022 and include the product code 83QKP, according to the FDA release.

Read more about recent Class I recalls of COVID-19 tests in the March 2022 issue of Diagnostic Testing & Emerging Technologies.