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Recall Observatory FDA recall evidence

Device 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.

Z-0064-2019

June 13, 2018

Class II

Product summary

Firm
Leica Microsystems, Inc.
Event
Event 80916
Status
Terminated
Classification
Class II
Quantity
67 units
Official record key
device-enforcement:Z-0064-2019

Official wording

Reason: 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.

Code information: Serial Numbers: 70-78, 111-112, 120-175

Distribution pattern: Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.