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C. DIFFICILE TOX-B TEST
TECHLAB, INC. · Model T5003 · UDI-DI 00857031002264
LLH
Prescription
10
510(k) clearances
8
Adverse events (1 deaths)
11
Recalls
24
Facilities
Description
The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with 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.