Z-0064-2019Class II

Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated

Name: Z-0064-2019 Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated
Creator: Leica Microsystems, Inc.
Published: 2018-06-13
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2018-06-13 / Terminated / root cause: design

FDA source

Leica Microsystems, Inc. began a recall of Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and... on 2018-06-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0064-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-13
Posted: 2018-10-03
Terminated: 2019-03-18
Recalling firm: Leica Microsystems, Inc.
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.
Product code: KPA Slide Stainer, Automated
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On approximately 06/13/2018 sent a Field Action Notices to consignees. Instructions included to make arrangements with their Leica Service Engineer to correct affected devices, ensure all appropriate personnel are made aware of the recall, and complete and return the Field Action Notice Return Response Form to confirm receipt and understanding of the recall notice.
Quantity in commerce: 67 units
Distribution: Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND
Product codes and lots: Serial Numbers: 70-78, 111-112, 120-175

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0064-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0064-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)