medical Class II Updated 2018-10-10

Leica Microsystems, Inc. recalls Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automa

Recalled Product

Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.


Hazard / Issue

These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 70-78, 111-112, 120-175
View official government recall

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