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C. Difficile Toxin Gene Amplification Assay
FDA product code OZN · Class 2 · Microbiology
24
Registered devices
31
Adverse events
8
Recalls
17
510(k) clearances
Devices with this code
Simplexa™ C. difficile Positive Control Pack — DIASORIN MOLECULAR LLCGenePOC™ CDiff — GenePoc IncSimplexa™ C.difficile Sample Prep Kit — DIASORIN MOLECULAR LLCToxigenic C. difficile Direct Test - Sample Prep — Vela Operations USA Inc.BD MAX™ System — BECTON, DICKINSON AND COMPANYARIES® C. difficile Assay — LUMINEX CORPORATIONRevogene® C. difficile — Meridian Bioscience Canada Incartus® C. difficile QS-RGQ MDx Kit — QIAGEN GmbHClostridium difficile (CDF) Stool Sample Preparation Kit — LUMINEX CORPORATIONClostridium difficile (CDF) Amplification Tray — LUMINEX CORPORATIONBD MAX™ Cdiff (US) — BECTON, DICKINSON AND COMPANYSimplexa™ C. difficile Direct — DIASORIN MOLECULAR LLCLyra — QUIDEL CORPORATIONClostridium difficile (CDF) Amplification Tray — NANOSPHERE, INC.Portrait Toxigenic C. difficile Assay — GREAT BASIN SCIENTIFIC, INC.Clostridium difficile (CDF) Stool Sample Preparation Kit — NANOSPHERE, INC.AmpliVue — QUIDEL CORPORATIONRevogene C. difficile — MERIDIAN BIOSCIENCE, INC.Clostridium difficile (CDF) Nucleic Acid Test Cartridge — LUMINEX CORPORATIONClostridium difficile (CDF) Extraction Tray — NANOSPHERE, INC.Toxigenic C. difficile Direct Test — Vela Operations USA Inc.Clostridium difficile (CDF) Nucleic Acid Test Cartridge — NANOSPHERE, INC.Clostridium difficile (CDF) Extraction Tray — LUMINEX CORPORATIONSolana — DIAGNOSTIC HYBRIDS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-05 | Meridian Bioscience Inc | The affected lots show a decline in performance over time, which may lead to false-negative results. |
| 2025-09-23 | Becton Dickinson & Co. | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti |
| 2023-06-05 | Luminex Corporation | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Par |
| 2022-06-17 | Luminex Corporation | There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, re |
| 2013-10-16 | Nanosphere, Inc. | Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested wit |
| 2013-10-10 | Nanosphere, Inc. | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip |
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