FDA (Devices) recall action 67665
The FDA (Devices) publishes a recall like this one as 80 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 80 pages.
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
The agency’s own wording, quoted from the enforcement report.
LumiQuick Diagnostics Inc. is recalling PCP Test Strips distributed to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Methylphenidate Test Cards because they were shipped to locations without required FDA regulatory clearance.
LumiQuick Diagnostics is recalling MDMA/Ecstasy Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling EDDP Strips because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling all lots of the Adenovirus Antigen Test Card because they were shipped to locations without approved FDA applications.