FDA Medical Device Recalls (openFDA)
Leica Microsystems, Inc.: 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.
- Recall number
- Z-0064-2019
- 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.
- Status
- Terminated
- Initiated
- 2018-06-13
- Posted
- not on file
- Terminated
- 2019-03-18
- 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.
- 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
- 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
- Lot, serial or model codes
- Serial Numbers: 70-78, 111-112, 120-175
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPA
- Firm FEI
- 3000210133
- Firm city
- Buffalo Grove
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28