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Epredia

SHANDON DIAGNOSTICS LIMITED · Model Dispense Nozzle Short · UDI-DI 05051663518239

IDW
1
510(k) clearances
4
Adverse events
1
Recalls
31
Facilities

Description

HistoStar Tissue Embedding System - Accessory

Recalls

DateFirmReason
2024-05-10LEICA BIOSYSTEMS NUSSLOCH GMBHAn issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.