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HARDY DIAGNOSTICS · Model 3001 · UDI-DI 00816576023646

JSHJSIKZI
10
510(k) clearances
181
Adverse events
2
Recalls
30
Facilities

Description

EMB/TSA with Blood/Staph Select, 15x100, Triplate, 10/pk For cultivation and differentiation of microorganisms Section I: ECM Levine Agar Section II: TSA with 5% Sheep Blood Section III: Staph Selective

Recalls

DateFirmReason
2025-07-11Remel, IncThe products may contain surface and subsurface contamination of Listeria monocytogenes.
2017-03-24Remel IncConfirmed complaint of surface contamination of Listeria monocytogenes.

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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.