FDA-Device2018-10-10Class II

Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.

Leica Microsystems, Inc.
Hazard

Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.

Sold states
Distribution in US state of MO.
Affected count
1 unit
Manufactured in
1700 Leider Ln, Buffalo Grove, IL, United States
Products
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0019-2019

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