Reported Oct 10, 2018 · Terminated
Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a…
Leica Microsystems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leica Microsystems, Inc. · 1700 Leider Ln · Buffalo Grove, IL · 60089-6622
Is this the product you have?
- Leica Biosystems HistoCore SPECTRA ST, Slide Stainer
- Automated Product UsageThe intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens
- Lot codes and dates
- Serial Numbers
70-78111-112120-175
- Serial Numbers
- Amount recalled
- 67 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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