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| Ebolavirus under an electron microscope--Courtesy of CDC |
The FDA cracked down on San Diego's LuSys Laboratories for selling an unapproved diagnostic for Ebola. It announced that the company recalled all 2,000+ units of its Ebola Virus One Step Test Kits in March and destroyed any remaining kits. It deemed the recall Class I, meaning exposure to the violative product "will cause serious adverse health consequences or death."
The unapproved diagnostic was distributed to California, and abroad to Canada, Sierra Leone, and Denmark, FDA says.
The kit consists of a test device, lancet, alcohol pad and buffer vial. Some of the components were optional, according to the recall notice. Some of the kits had an extraction tube for a feces test and swab for a nasal test (25 to be precise).
The FDA posted 8 separate recalls in its database to account for the varying product configurations. Two of the recalls, affecting more than 2,000 kits, account for the vast majority of the recalled units.
LuSys sent a medical device recall letter urging all customers of the Ebola Virus One Strep Test Kit to discontinue use of the diagnostic and return it to the company on March 13. The letter informed users that the product was not approved by the FDA.
According to the LuSys website, the company makes a variety of tests for conditions like heart disease, cancer, fetal health and food-borne disease. Most of the diagnostics are for export only.
The Ebola scare in the U.S. is dampening after the feared outbreak of the disease failed to materialize in this country. The fight continues in West Africa, where the disease is diminishing, but still present.
The race to sell the first approved (or in this case unapproved) diagnostic for Ebola continues, for the disease has killed more than 10,000 people, according to the World Health Organization.
As the recall notice demonstrates, the panic has resulted in questionable behavior on the part of industry.
In another example, Aethlon Medical ($AEMD) just filed for FDA approval of its device to treat the disease using an uncommon pathway for devices that treat rare conditions. Seeking permission to use the device via FDA's Emergency Use Authorization provision would seem to make more sense. TheStreet's Adam Feuerstein tweeted that the filing is a "stock promoting stunt."
He pointed to the company's November press release claiming that it had sent the unapproved device to a hospital in Nebraska to assist an American doctor who contracted the disease while treating patients in Africa. It turns out that although Aethlon had shipped the unapproved device, it was never used, nor even requested, according to the hospital's spokesperson.
But the penny stock's price did rise following the announcement that the device had been shipped, and a $3.3 million financial transaction was made shortly thereafter.
- read the recall notice
- view all 8 of the notices by entering April 9 on the FDA recall database