Z-2779-2015 Class III Terminated

Recalled by Leica Microsystems, Inc. — Buffalo Grove, IL

FDA device recall Z-2779-2015 was initiated by Leica Microsystems, Inc. on Aug 5, 2015 and is designated Class III. 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. The recall status is terminated (terminated Jan 5, 2017). Affected quantity: 901.

Recall Details

Product Type
Devices
Report Date
Sep 23, 2015
Initiation Date
Aug 5, 2015
Termination Date
Jan 5, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
901

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.

Distribution Pattern

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.

Code Information

Product Code: Leica ASP200S/ASP300S with Serial Numbers: 5682; 5886; 5264; 5267; 5356; 5259; 5956; 5946; 5794; 5385; 5929; 5301; 5401; 5310; 5530; 5909; 5804; 5272; 5724; 5796; 5807; 5446; 5435; 5670; 5947; 5348; 5434; 5388; 5366; 6000; 6131; 5407; 6040; 5799; 5815; 5737; 5706; 5381; 5416; 5673; 5875; 5962; 6041; 6042; 5266; 5948; 5693; 6021; 5610; 5798; 5926; 5387; 5349; 5273; 6115; 5612; 5965; 5955; 5260; 5725; 5871; 5873; 5874; 5562; 6046; 5386; 5977 ;5889; 5398; 6062; 5609; 6015; 5734; 5403; 5289; 5426; 6149; 5663; 6045

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2779-2015
openFDA file date
Oct 27, 2026
Loaded by RegDataLab
Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.