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HARDY DIAGNOSTICS · Model R15 · UDI-DI 00819398023115
10
510(k) clearances
78
Adverse events
5
Recalls
15
Facilities
Description
BHI (Brain Heart Infusion) Broth, 2ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Brain Heart Infusion Broth) For the cultivation of microorganisms.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-30 | bioMerieux, Inc. | There is potential to provide an incorrect organism identification. |
| 2015-11-18 | Hardy Diagnostics | The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination. |
| 2012-12-10 | Becton Dickinson & Co. | Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species. |
| 2012-02-20 | Becton Dickinson & Co. | In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended. |
| 2009-12-21 | Remel, Inc | Product failure - Failure to grow quality control strains of Streptococcus pneumoniae. |
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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.