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Terminated

Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.

FDA Recall Z-0019-2019 · Posted None

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeKIM
Date Initiated2018-09-04
Date Terminated2020-07-10
Product Quantity1 unit

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.

Firm 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.

Root Cause

Process design

Distribution Pattern

Distribution in US state of MO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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