FDA-Device2015-09-23Class III

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.

Leica Microsystems, Inc.
Hazard

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.

Sold states
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, GB, HU, ID, IN, IT, JM, JP, KR, LK, MA, MT, MY, NL, NZ, PA, PE, PH, PL, PT, RO, RU, SA, SE, SG, TH, TR, TW, VN and ZA.
Affected count
901
Manufactured in
1700 Leider Ln, Buffalo Grove, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2779-2015

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