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 Fecal Occult Blood Test Cards because they were shipped to locations without approved FDA applications or clearances.
LumiQuick Diagnostics Inc. is recalling THC Test Cards shipped to US locations without approved FDA applications.
LumiQuick Diagnostics is recalling Morphine Test Cards because they were shipped to locations without required FDA approvals.
LumiQuick Diagnostics is recalling all lots of its Dengue NS1 Ag/IgG/M Ab Duo Test Cards because they were shipped to US locations without the required FDA clearance.
LumiQuick Diagnostics is recalling PSA Test Cards shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling EDDP Test Cards because they were shipped to locations without required FDA approvals.
LumiQuick Diagnostics is recalling all lots of its Rotavirus Test Card because they were shipped to US locations without approved FDA clearance.
LumiQuick Diagnostics is recalling K2 Test Strips because they were shipped to locations without FDA clearance.
LumiQuick Diagnostics is recalling Benzodiazepine Strips because they were shipped to US locations without required FDA clearances.
LumiQuick Diagnostics is recalling Strep A Test Cards because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling fecal occult blood test strips shipped to US locations without approved regulatory clearance.
LumiQuick Diagnostics Inc. is recalling all lots of Tramadol Strips (Catalog 74003) because they were shipped to US locations without approved FDA applications or clearance.
LumiQuick Diagnostics is recalling Cocaine Test Cards because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Barbiturate Strips shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Malaria pf Antigen Test Cards because they were shipped to locations without approved FDA applications or clearance.
LumiQuick Diagnostics is recalling Salmonella typhi IgG/IgM Duo Tests because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling Propoxyphene Test Strips because they were shipped to US locations without approved applications for PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics Inc. is recalling H. Pylori Antibody Test Cards because they were shipped to locations without required FDA regulatory clearances.
LumiQuick Diagnostics is recalling Methadone Test Strips because they were shipped to US locations without approved applications for PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics Inc. is recalling Adeno/Rota Combo Test Cards because they were shipped to US locations without required FDA regulatory approvals.
LumiQuick Diagnostics is recalling Propoxyphene Test Strips because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling all lots of THC Strip (Catalog 74035) because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Syphilis Test Cards because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics is recalling Clonazepam Test Cards because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Oxycodone Strips because they were shipped to US locations without required FDA clearance.