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C. DIFFICILE TOX A/B II
TECHLAB, INC. · Model 30397 · UDI-DI 00857031002103
LLH
Prescription
1
510(k) clearances
8
Adverse events (1 deaths)
11
Recalls
24
Facilities
Description
The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
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 potential delayed result |
| 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 difficile in patient sa |
| 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 there is potential for |
| 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 increased invalid test rat |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.