Recall Z-0019-2019— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2018-09-04, terminated 2020-07-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.. Reason: Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-04
- Terminated
- 2020-07-10
- Firm location
- Buffalo Grove, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.