CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
Leica Biosystems HistoCore Spectra ST, Slide Stainer, Automated recalled
Leica Microsystems is recalling Leica Biosystems HistoCore Spectra ST, Slide Stainer, Automated, distributed nationwide in the US. The recall was initiated on 13 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0064-2019
- FDA event ID
- 80916
- Recalling firm
- Leica Microsystems, Buffalo Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jun 2018
- FDA classified
- 3 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 13 Jun 2018 | Recall initiated by company | |
| 3 Oct 2018 | Classified by FDA | +112 days |
| 10 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND
Nationwide ArizonaCaliforniaColoradoKansasMassachusettsMissouriNew JerseyOhioWisconsin
Questions about this recall
Is Leica Biosystems HistoCore Spectra ST, Slide Stainer, Automated recalled?
Yes. Leica Microsystems recalled Leica Biosystems HistoCore Spectra ST, Slide Stainer, Automated on 13 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-0064-2019.
Why was it 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.
Which lots are affected?
Serial Numbers: 70-78, 111-112, 120-175
Where was it sold?
Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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