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N/A
HARDY DIAGNOSTICS · Model 6036 · UDI-DI 00816576026685
10
510(k) clearances
78
Adverse events
5
Recalls
15
Facilities
Description
Tryptic Soy Broth (TSB), 10ml, 16x125mm tube, optically clear, order by the package of 10 (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also known as Soybean-Casein Digest Broth, USP.
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.