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C. DIFF QUIK CHEK
TECHLAB, INC. · Model 30390 · UDI-DI 00857031002141
MCB
Prescription
1
510(k) clearances
9
Adverse events
4
Recalls
8
Facilities
Description
The C. DIFF QUIK CHEK test is a rapid membrane 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, 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 |
| 2007-12-04 | Biosite Inc | False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed wi |
| 2002-12-26 | Meridian Bioscience Inc | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. |
| 2002-12-26 | Meridian Bioscience Inc | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. |
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