Z-0019-2019Class II

Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples...

Name: Z-0019-2019 Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples...
Creator: Leica Microsystems, Inc.
Published: 2018-09-04
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2018-09-04 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics on 2018-09-04. FDA classified it as Class II and gives the reason as "Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0019-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-04
Posted: 2018-10-03
Terminated: 2020-07-10
Recalling firm: Leica Microsystems, Inc.
Product: Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
Product code: KIM Device For Sealing Microsections
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm issued a Field Action Notice by letter on 09/05/2018. The notice explained the issue and the possible hazard. The firm will schedule a visit with a service engineer to perform the correction.
Quantity in commerce: 1 unit
Distribution: Distribution in US state of MO.
Product codes and lots: Serial Number 102

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0019-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0019-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03

Product code KIM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)