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C. DIFF CHEK - 60
TECHLAB, INC. · Model T5025B · UDI-DI 00857031002233
LLH
Prescription
1
510(k) clearances
8
Adverse events (1 deaths)
11
Recalls
24
Facilities
Description
The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, 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.