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# Celltrion Covid Test Recall is Class 1
- URL: https://www.fdaweb.com/celltrion-covid-test-recall-is-class-1/
- Published: 2022-03-16T12:00:00.000Z
- Updated: 2026-09-14T17:36:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151374

FDA says a Celltrion USA 2/28 recall of its Celltrion DiaTrust Covid-19 Ag Rapid Test is Class 1\. Some 45,500 units that were distributed between 6/2 and 12/21/21 were recalled due to a high number of false-positive reports for some tests, an agency [statement](https://www.fda.gov/medical-devices/medical-device-recalls/celltrion-usa-recalls-celltrion-diatrust-covid-19-ag-rapid-tests-false-positive-test-results-and?ref=fdaweb.com) says. Also, FDA says, the tests’ labeling includes a shelf life of 18 months but the agency’s emergency use authorization specifies the test may only be used for 12 months.

“Although there have been no reports of injuries, adverse health consequences or death associated with the use of the test,” FDA says, “false positive or false negative results from improper use of these tests could lead to further exposure of uninfected individuals to SARS-CoV-2 virus. There are also serious injury risks if someone who is not trained to collect a nasopharyngeal swab sample attempts to do so.”