Celltrion USA is voluntarily recalling two lots of Research Use Only DiaTrust COVID-19 Ag Rapid Test Kits because of the potential that they may be misused for diagnostic purposes.
These Test Kits contain 25 individual tests each. These DiaTrust COVID-19 Ag Rapid Test Kits are intended for research use only (RUO) by trained laboratory personnel specifically instructed and trained for performing rapid lateral flow tests. 4,168 Test Kits containing 104,200 tests were shipped from December 18, 2020.
The test kits are labeled for Research Use Only as shown in the picture.
However, it is possible that these Test Kits have been used for diagnostic purposes, contrary to the product labeling.
The company is issuing this voluntary recall as a precaution.
Usage of RUO labeled tests in a non-RUO setting can result in usage of nasopharyngeal swabs by laypersons which can result in physical harm such as nose bleeds and inaccurate collection of the sample from the proper anatomical location which can lead to false negative test results. Failure to conduct serial testing of asymptomatic persons can also lead to false negative test results.
Risk of false negative test results can include significant morbidity and death. Although a negative result does not rule out SARS-CoV-2 infection, a false negative has the potential to result in initiation of inappropriate treatment and a delay in correct diagnosis.
A false negative result can trigger a misallocation of health care resources, as additional evaluations are pursued in the effort to establish the true diagnosis. A false negative result can contribute to further spread of the disease by not identifying individuals infected with SARS-CoV-2.
Source: Company Press Release
