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HARDY DIAGNOSTICS · Model K112 · UDI-DI 00819398020718

510(k) clearances

Adverse events

Recalls

Facilities

Description

Todd Hewitt Broth, 15x103mm Tube, 1ml. Hardy Diagnostics Todd Hewitt Broth is recommended for the production of antigenic streptococcal hemolysin and the cultivation of streptococci prior to serological grouping. It is also recommended for the cultivation of beta-hemolytic streptococci, pneumococci, and other fastidious organisms.

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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Data 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.