The U.S. Food and Drug Administration has issued another Class I recall for Celltrion’s DiaTrust COVID-19 Ag Rapid Test diagnostic kit distributed in the U.S., making it the regulator’s third such order in less than two months.
The Class I recall is the most serious type of recall issued by the FDA and relates to the use of devices that can cause serious injury or death.
The FDA has cleared the kit for point-of-care use only. It requires a nasopharyngeal sample taken by a health care provider and sent to a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory for processing.
The US agency issued the recall order, the kit may have been distributed to unauthorized users.
“Emergency use of these tests is limited to authorized laboratories, and use of these tests in unlicensed environments may present an increased risk of false results because individuals performing these tests may not have the qualifications or the training needed to administer them safely and correctly,” the FDA said in its recall notice.
Although there have been no reports of injuries, adverse health consequences, or deaths associated with the use of these affected products, false positive or false negative results resulting from the improper use of these tests could result in additional exposure of uninfected people to the Covid-19 virus, the FDA added.
The agency also highlighted the risks of serious injury if someone without the proper training tries to take a nasopharyngeal swab sample.
The recall affects 311,100 units distributed in the United States during the three months between December and February.
Following the FDA recall order, Celltrion USA notified customers of this issue via email. He asked them to provide a CLIA certificate number and contact information to their distributor on April 5.
The company also asked customers without CLIA certification not to use the test kits currently in stock, to quarantine them and to return the product to the distributor, along with an acknowledgment of receipt and an attached receipt form. to email.
“This is a case where a primary distributor purchased the kit, approved only for CLIA-certified laboratories and institutions, from Celltrion USA and sold it to secondary or tertiary distributors who do not have CLIA ID,” a company official told Korea Biomedical. Review Monday. “However, only a small portion of the total cast was recalled.”
Celltrion USA and its distributors are currently performing recalls faithfully in accordance with FDA guidelines and have mostly completed product recalls.
The most recent recall follows a recall of 119,600 units of the Celltrion DiaTrust COVID-19 Ag Rapid Test diagnostic kit distributed in the United States on March 23.
The FDA ordered the recall because the diagnostic kits in distribution were for research use only (RUO) and not for commercial sale. Celltrion USA voluntarily recalled the kits, but the FDA issued a Class 1 recall.
On March 22, the FDA also issued a recall for 45,500 units of Celltrion’s product in the United States due to the discovery of possible false positive results for certain products and an error in the description of the expiration date. , and the possibility of false positive detection.
Notably, the FDA found that the company set the product’s shelf life at 18 months, even though an emergency use authorization gives a shelf life of 12 months.