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Thermo Fisher
SHANDON DIAGNOSTICS LIMITED · Model Histostar · UDI-DI 00505166300228
1
510(k) clearances
4
Adverse events
1
Recalls
31
Facilities
Description
220-240V 50/60 Hz
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-10 | LEICA BIOSYSTEMS NUSSLOCH GMBH | An 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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Get your free API keyRead the docsData 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.