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HARDY DIAGNOSTICS · Model A70 · UDI-DI 00816576024230

JSJ

510(k) clearances

538

Adverse events

Recalls

Facilities

Description

Selective Strep Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Selective Strep Agar is a selective medium recommended for use in the primary isolation of all Streptococcus species, including streptococcal groups A (S. pyogenes), B (S. agalactiae), C, D, F, G, and S. pneumoniae, especially from repiratory specimens.

Recalls

Date	Firm	Reason
2026-02-05	Remel, Inc	Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
2018-08-02	Acumedia Manufacturers, Inc.	The product is labeled with an incorrect expiration date.
2016-03-21	Hardy Diagnostics	Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to produc
2013-06-06	Becton Dickinson & Co.	Microbiological identification media may exhibit reduced levels of Vancomycin.
2013-06-06	Becton Dickinson & Co.	Microbiological identification media may exhibit reduced levels of Vancomycin.
2013-06-06	Becton Dickinson & Co.	Microbiological identification media may exhibit reduced levels of Vancomycin.

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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.