Z-2804-2015 Class II Terminated
FDA device recall Z-2804-2015 was initiated by Leica Microsystems, Inc. on Jul 27, 2015 and is designated Class II. Reason for recall: The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor 3, thus… The recall status is terminated (terminated Jan 5, 2017). Affected quantity: U.S. Quantity Distributed: 163 systems; Foreign Quantity Diistributed: 410 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2015
- Initiation Date
- Jul 27, 2015
- Termination Date
- Jan 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- U.S. Quantity Distributed: 163 systems; Foreign Quantity Diistributed: 410 systems.
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US including AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH,PA, SC, TN, TX, VA, WA, WI, WV and District of Columbia. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Czech Republic , Germany, Spain, France, England, Georgia, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lithuania, Myanmar, Mexico, Malaysia, Netherland, Norway, Peru, Philippines, Poland, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey, Taiwan, and South Africa.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2804-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026