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HARDY DIAGNOSTICS · Model U10 · UDI-DI 00819398028271
10
510(k) clearances
9
Adverse events
13
Recalls
54
Facilities
Description
Phosphate Buffer, 500ml fill, 500ml polycarbonate bottle, each Phosphate Buffer, 500ml for the preparation of specimens for AFB culture
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.