Z-0019-2019 Class II Terminated
FDA device recall Z-0019-2019 was initiated by Leica Microsystems, Inc. on September 4, 2018 and is designated Class II. 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. The recall status is terminated (terminated July 10, 2020). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- September 4, 2018
- Termination Date
- July 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
Distribution Pattern
Distribution in US state of MO.
Code Information
Serial Number 102