FDA (Devices) recall action 70668
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Lusys Laboratories is recalling 1,055 Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Lusys Laboratories is recalling 5 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.
Lusys Laboratories is recalling 1,015 units of Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic use.
Lusys Laboratories is recalling 40 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.
Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.
Lusys Laboratories is recalling 80 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.