Medical device recalls Moderate risk

Leica Microsystems, Inc. recalls Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microsc…

Recall date
September 4, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0019-2019
FDA classification
Class II
Brand / firm
Leica Microsystems, Inc.
Sold / distributed
Distribution in US state of MO.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever Leica Microsystems, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Leica Microsystems, Inc.