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 Barbiturate Test Cards because they were shipped to 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.
LumiQuick Diagnostics Inc. is recalling Buprenorphine Test Strips because they were shipped to locations without FDA approval.
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 Strep A Test Cards because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling urine alcohol tests shipped to US 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 PCP Test Strips distributed to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics Inc. is recalling Tuberculosis Antibody Test Card Serum because it was shipped to locations without required FDA clearances.
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 is recalling Amphetamine Strips shipped to US locations without approved PMA, IDE, or 510(k) clearance.
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 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 Methamphetamine Strips because they were shipped to US locations without required FDA clearances.
LumiQuick Diagnostics is recalling Methadone Test Cards because they were shipped to locations without approved FDA applications or clearance.
LumiQuick Diagnostics is recalling Syphilis Test Cards (Serum) because they were shipped to US locations without approved PMA, IDE, or 510(k) 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 is recalling Methylphenidate Test Strips because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics Inc. is recalling PSA Test Cards (Whole Blood) because they were shipped to US locations without approved FDA applications or 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 is recalling Fentanyl Test Strips because they were shipped to US locations without approved FDA applications.
LumiQuick Diagnostics is recalling Morphine Strips (2000) because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Morphine Strip (300) products distributed in California, Florida, New Jersey, Texas, and New York because they were shipped to locations without approved applications for PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Clonazepam Test Cards because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.