FDA recall Z-0019-2019

Product

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

Reason for recall

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

Distribution

Distribution in US state of MO.

Key facts

Status

Terminated

Initiation date

2018-09-04

Report date

2018-10-10

Termination date

2020-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buffalo Grove, IL, United States

Primary source

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