Leica Microsystems, Inc. recalls The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an auto…

Recall date

July 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2804-2015

FDA classification

Class II

Brand / firm

Leica Microsystems, Inc.

Sold / distributed

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, Chi…

Why it was recalled

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 not completing a 5 litre fill.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.