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CarboFerm™
HARDY DIAGNOSTICS · Model Z98 · UDI-DI 00816576029068
10
510(k) clearances
8
Adverse events
13
Recalls
54
Facilities
Description
CarboFerm™ I, rapid carbohydrate test for Neisseria and Moraxella, 24 tests per kit For the rapid identification and differentiation of Neisseria spp., including N. gonorrhoeae and N. meningitidis, and Moraxella (Branhamella) catarrhalis. CarboFerm™ uses acid production from carbohydrates to differentiate and identify Neisseria species and M. catarrhalis. Performs a glucose, lactose, maltose, sucrose, and butyrate test
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-23 | Becton Dickinson & Co. | The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an erro |
| 2016-01-08 | BioMerieux SA | Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked |
| 2014-10-23 | Remel Inc | A reagent within the test may return false negative results. |
| 2014-10-23 | Remel Inc | A reagent within the test may return false negative results. |
| 2014-03-17 | Remel Inc | A reagent contained within the product may return false negative results. |
| 2014-03-17 | Remel Inc | A reagent contained within the product may return false negative results. |
| 2014-03-06 | BioMerieux SA | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra |
| 2014-03-06 | BioMerieux SA | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra |
| 2014-03-06 | BioMerieux SA | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra |
| 2014-03-06 | BioMerieux SA | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra |
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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.