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HARDY DIAGNOSTICS · Model R32 · UDI-DI 00819398023399

JSH
10
510(k) clearances
173
Adverse events
2
Recalls
29
Facilities

Description

TSI (Triple Sugar Iron) Agar Slant, 4ml, 13x100mm tube, order by the package of 20 (Triple Sugar Iron Agar) For the identification of gram negative bacilli.

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.