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ImmunoCard C. difficile GDH
MERIDIAN BIOSCIENCE, INC. · Model 716050 · UDI-DI 00840733101793
MCB
Prescription
1
510(k) clearances
9
Adverse events
4
Recalls
8
Facilities
Description
ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
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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