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C. DIFF QUIK CHEK COMPLETE

TECHLAB, INC. · Model T30550C · UDI-DI 00857031002158

LLH Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting 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. As with other C. difficile tests, 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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Data 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.