Medical Device Recall: Z-0019-2019

FDA Recalls dataset · Firm: Leica Microsystems, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2018-09-04 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-2019.

Recall Res Number
Z-0019-2019
Recalling Firm / Manufacturer
Leica Microsystems, Inc.
FEI Number
3000210133
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2018-09-04
Date Posted
N/A
Date Terminated
2020-07-10
Product Code
KIM
Event Number
80986
Product Quantity
1 unit
Product Description Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
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.
Action Details 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.
Distribution Pattern Distribution in US state of MO.
Code Information / Serial Numbers Serial Number 102

Related Establishments / Registrations

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