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Epredia

SHANDON DIAGNOSTICS LIMITED · Model HM525 NX system, 110-120V · UDI-DI 05051663005395

IDP
1
510(k) clearances
40
Adverse events
10
Recalls
21
Facilities

Recalls

DateFirmReason
2025-01-30LEICA BIOSYSTEMS NUSSLOCH GMBHFirm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potent
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potent
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potent
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potent
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potent
2024-09-04LEICA BIOSYSTEMS NUSSLOCH GMBHAs part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potent
2019-05-03Leica Microsystems, Inc.The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious i
2010-09-23Thermo Fisher ScientificThrough internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfectio
2010-09-23Thermo Fisher ScientificThrough internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfectio

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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.