CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
Leica HistoCore Spectra CV Coverslipper, used recalled
Leica Microsystems is recalling Leica HistoCore Spectra CV Coverslipper, used in preparation of histological and, distributed in Missouri. The recall was initiated on 4 Sep 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-0019-2019
- FDA event ID
- 80986
- Recalling firm
- Leica Microsystems, Buffalo Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2018
- FDA classified
- 3 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Sep 2018 | Recall initiated by company | |
| 3 Oct 2018 | Classified by FDA | +29 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
Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.
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 HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
Where it was distributed
Distribution in US state of MO.
Questions about this recall
Is Leica HistoCore Spectra CV Coverslipper, used in preparation of histological and recalled?
Yes. Leica Microsystems recalled Leica HistoCore Spectra CV Coverslipper, used in preparation of histological and on 4 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0019-2019.
Why was it recalled?
Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.
Which lots are affected?
Serial Number 102
Where was it sold?
Distribution in US state of MO.
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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