Recall Z-2779-2015— Leica Microsystems, Inc.
Class III · Terminated
Class III FDA medical device recall by Leica Microsystems, Inc., initiated 2015-08-05, terminated 2017-01-05. FDA's recall record names no specific 510(k) clearance for this event. Product: The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.. Reason: The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-08-05
- Terminated
- 2017-01-05
- Firm location
- Buffalo Grove, IL, United States
Product description
The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Reason for recall
The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.