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Epredia

SHANDON DIAGNOSTICS LIMITED · Model Loading Tray Complete · UDI-DI 05051663517485

KIM
1
510(k) clearances
10
Adverse events
1
Recalls
12
Facilities

Description

ClearVue coverslipper- Accessory

Recalls

DateFirmReason
2018-09-04Leica Microsystems, Inc.Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.

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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.