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 all lots of its Dengue IgG/IgM tests 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 Inc. is recalling Fentanyl Test Cards because they were shipped to US locations without approved FDA applications.
LumiQuick Diagnostics Inc. is recalling Tuberculosis Antibody Test Card Serum because it was shipped to locations without required FDA clearances.
LumiQuick Diagnostics is recalling all lots of the Ketamine Test Card because they were shipped to US locations without required FDA clearance.
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 is recalling CK-MB Test Cards shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics is recalling Tramadol Test Cards because they were shipped to US locations without required FDA approvals.
LumiQuick Diagnostics is recalling Methamphetamine Strips because they were shipped to US locations without required FDA clearances.
LumiQuick Diagnostics Inc. is recalling CK-MB Test Cards (Whole Blood) because they were shipped to US locations without required FDA 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 is recalling Oxycodone Test Cards because they were shipped to US locations without required FDA approvals.
LumiQuick Diagnostics is recalling K2 Test Cards because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics Inc. is recalling Benzodiazepine Test Cards because they were shipped to US locations without approved FDA applications.
LumiQuick Diagnostics is recalling Cardiac Panel Tests because they were shipped to locations without required FDA approvals.
LumiQuick Diagnostics is recalling MDMA/Ecstasy test strips because they were shipped to locations without required FDA regulatory clearance.
LumiQuick Diagnostics Inc. is recalling Malaria pan Antigen Tests because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Fentanyl Test Cards because they were shipped to US locations without required FDA approvals.
LumiQuick Diagnostics is recalling Buprenorphine Test Cards because they were shipped to locations without required FDA approvals.
LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Rickettsia IgG/IgM Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics is recalling H. Pylori Antigen Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics is recalling Cocaine Strips shipped to US locations without approved FDA applications.
LumiQuick Diagnostics is recalling urine alcohol tests shipped to US locations without required FDA clearance.