Home › Device types › LLH
Reagents, Clostridium Difficile Toxin
FDA product code LLH · Class 1 · Microbiology
35
Registered devices
8
Adverse events
11
Recalls
42
510(k) clearances
Devices with this code
C. DIFFICILE TOX A/B II — TECHLAB, INC.CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS — DIESSE DIAGNOSTICA SENESE SPAC. DIFFICILE TOXIN ANTITOXIN KIT — TECHLAB, INC.Remel — REMEL, INC.C. DIFF CHEK - 60 — TECHLAB, INC.C. DIFF QUIK CHEK COMPLETE — TECHLAB, INC.C. DIFFICILE TOX A/B II — TECHLAB, INC.TOX A/B QUIK CHEK — TECHLAB, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.ProSpecT™ Wash Buffer — OXOID LIMITEDC. DIFFICILE TOX-B TEST — TECHLAB, INC.C. DIFF QUIK CHEK COMPLETE — TECHLAB, INC.Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.C. DIFF CHEK - 60 — TECHLAB, INC.C. DIFF CHEK - 60 — TECHLAB, INC.ProSpecT C. difficile Toxin A/B Microplate — OXOID LIMITEDC. DIFFICILE TOX A/B II — TECHLAB, INC.Remel — REMEL, INC.ImmunoCard Toxins A & B — MERIDIAN BIOSCIENCE, INC.VIDAS® C. difficile Toxin A & B — BIOMERIEUX SAC. DIFF QUIK CHEK COMPLETE — TECHLAB, INC.Xpert C. difficile — CEPHEIDC. DIFF QUIK CHEK COMPLETE — TECHLAB, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2013-10-11 | Becton Dickinson & Co. | An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium dif |
| 2013-09-16 | Sekisui Diagnostics LLC | Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that th |
| 2012-08-20 | Remel Inc | The firm is recalling the products due to a potential for false negative test results. |
| 2012-08-20 | Remel Inc | The firm is recalling the products due to a potential for false negative test results. |
| 2012-05-22 | Becton Dickinson & Co. | Leakage in Cepheid SmartCycler reaction tubes. |
| 2012-05-22 | Becton Dickinson & Co. | Leakage in Cepheid SmartCycler reaction tubes. |
| 2012-05-22 | Becton Dickinson & Co. | Leakage in Cepheid SmartCycler reaction tubes. |
| 2010-03-05 | Becton Dickinson & Co. | In vitro diagnostic test kits do not perform to specifications. |
| 2006-06-02 | Meridian Bioscience Inc | The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increa |
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