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HARDY DIAGNOSTICS · Model R70 · UDI-DI 00819398023573

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

Description

KIA (Kligler Iron Agar) Slant, 13x100mm tube, 4.5ml fill, order by the package of 20 (Kligler Iron Agar) For the identification of gram negative enteric bacteria based on hydrogen sulfide production and the fermentation of dextrose and lactose.

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.