Leica Microsystems, Inc. recalls The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Proc…

Recall date

August 5, 2015

Source

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

Recall number

Z-2779-2015

FDA classification

Class III

Brand / firm

Leica Microsystems, Inc.

Sold / distributed

Worldwide Distribution - US including U.S. including AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, WV and District of Columbia. Internationall to AE, AT, AU , BD , BE, BF, BG,BR, CA, CL, CN, CO, CR, DE, DK, EC, EG, ES, ET, FI, FR…

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.