Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
This recall has been terminated (originally issued September 4, 2018).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- September 4, 2018
- Terminated
- July 10, 2020
- Recall Number
- Z-0019-2019
- Quantity
- 1 unit
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
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
Distribution in US state of MO.
Lot / Code Info
Serial Number 102
Root Cause
Process design
Action Taken
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.
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