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 is recalling Fentanyl Test Strips because they were shipped to US locations without approved FDA applications.
LumiQuick Diagnostics is recalling Cardiac Panel Test Cards because they were shipped to locations without approved regulatory clearance.
LumiQuick Diagnostics is recalling Salmonella typhi/paratyphi Antigen Tests because they were shipped to locations without FDA approval.
LumiQuick Diagnostics is recalling Myoglobin Test Cards because they were shipped to locations without FDA clearance.
LumiQuick Diagnostics is recalling Methylphenidate Test Strips because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics is recalling PCP Test Cards because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling Morphine Test Cards because they were shipped to US locations without required FDA approvals.
LumiQuick Diagnostics Inc. is recalling all lots of its Saliva Alcohol Test (Catalog 74001) because the products were shipped to US locations without approved regulatory clearance.
LumiQuick Diagnostics is recalling Barbiturate Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics is recalling all lots of Syphilis Test Strips (Serum) because they were shipped to locations without approved FDA clearance.
LumiQuick Diagnostics Inc. is recalling Myoglobin Test Cards (Serum) because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics Inc. is recalling its Drugs of Abuse Panel Test Device because it was shipped to locations without required FDA approvals.
LumiQuick Diagnostics is recalling Amphetamine Test Cards because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics Inc. is recalling Salmonella typhi Antigen Test Cards because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Amphetamine Strips shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics Inc. is recalling all lots of the Dengue NS1 Antigen Test Card because the products were shipped to US locations without approved regulatory clearance.
LumiQuick Diagnostics Inc. is recalling Malaria pf/pan Antigen Test Cards because they were shipped to locations without approved FDA applications or clearance.
LumiQuick Diagnostics Inc. is recalling Buprenorphine Test Strips because they were shipped to locations without FDA approval.
LumiQuick Diagnostics is recalling Morphine Strips (2000) because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling all lots of its Ketamine Strip because the products were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Methamphetamine Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics is recalling Methadone Test Cards because they were shipped to locations without approved FDA applications or clearance.
LumiQuick Diagnostics is recalling Legionella Test Cards shipped to US locations without approved FDA applications.
LumiQuick Diagnostics is recalling Malaria pf Antigen Test Cards because they were shipped to US locations without required FDA regulatory clearance.
LumiQuick Diagnostics is recalling H. Pylori Ab Test Cards because they were shipped to locations without approved FDA applications.