Leica recalls HistoCore SPECTRA ST slide stainers with serial numbers 70-78, 111-112, 120-175 due to incorrect safety specifications that could cause electrical shock if a fault occurs.
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.
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Contact the company
📍Recalling firmLeica Microsystems, Inc.1700 Leider Ln · Buffalo Grove, IL 60089-6622
“Leica HistoCore SPECTRA ST Slide Stainer Recall: Incorrect Safety Spec Causes Electrical.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70851-leica-histocore-spectra-st-slide-stainer-recall-incorrect-safety-spec. Based on FDA recall #Z-0064-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0064-2019%22&limit=1).
The FDA announced on June 13, 2018, that Leica Microsystems, Inc. is recalling the Leica Biosystems HistoCore SPECTRA ST Slide Stainer due to a hazardous voltage risk. The agency stated the recall was voluntary and firm-initiated.
According to the FDA, 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 accessible to the user, resulting in hazardous voltage.
Context
GovInfoNow's records show Leica Microsystems, Inc. has 15 other recalls on record since June 19, 2017. Other recent recalls of similar products include GE Allia Moveo X-ray System Recall (April 20, 2026), GE Medical Systems Allia IGS 7 Pulse X-Ray System Recall (April 20, 2026), and GE Medical Systems Allia IGS 3 Pulse X-Ray System Recall (April 20, 2026).
How to tell if you have this one
Check the serial number on the device, which falls within ranges 70-78, 111-112, or 120-175. The product is an automated slide stainer for laboratory use in preparing histological and cytological specimens.
Brand
Leica
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Identify the serial number on the device to confirm if it falls within the recalled ranges: 70-78, 111-112, or 120-175.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Kansas, Massachusetts, Missouri, New Jersey, Ohio, Wisconsin.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0064-2019 (June 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0064-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.