Recall of Certain Celltrion COVID-19 Antigen Tests
VDH asked VHCA-VCAL to relay to members the news that certain lot numbers of Celltrion COVID-19 antigen tests have been recalled. VDH does not know if the recalls are associated with any tests that were shipped to Virginia’s long term care facilities.
Of note, the FDA website notes the following, which would indicate affected facilities were already informed of the recall.
On February 28, 2022, Celltrion USA sent letters to some affected distributors and customers with the following instructions:
- discontinue use
- return all unused product
- complete and return Acknowledgement and Receipt Form
Here is the remainder of the information:
- Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests by Celltrion USA: Class I Recall – Due to False Positive Test Results and Unauthorized Shelf Life – Celltrion USA is recalling specific lots of the DiaTrust COVID-19 Ag Rapid Test due to a high number of false positive reports. Additionally, the tests’ [sic] labeling for the affected products includes a shelf life of 18 months. However, the FDA’s emergency use authorization specifies these tests may only be used for 12 months. For more information about this recall, refer to the announcement.
Posted in COVID-19

























