Leica Microsystems, Inc. recalls Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including…

Recall date

May 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1729-2019

FDA classification

Class II

Brand / firm

Leica Microsystems, Inc.

Sold / distributed

Distributed to Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District Of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska,…

Why it was recalled

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 injuries.

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 Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.