Cassettes, Tissue
Pathology · 21 CFR 864.3010
Recent MDR events
48 adverse event reports on file
- IP BIOPSY CASSETTE II, TAPED, PINKApr 23, 2026MalfunctionSimport Scientifique Inc.1419341-2026-00007
- IP ROUTINE VI TAPED, BLUEJan 21, 2026MalfunctionAcot Plastics Co Ltd1419341-2026-00002
- IP BIOPSY CASSETTE II, TAPED, GREENDec 22, 2025MalfunctionSimport Scientificque Inc.1419341-2025-00039
- IP BIOPSY CASSETTE II, TAPED, PINKNov 6, 2025MalfunctionSimport1419341-2025-00037
- IP BIOPSY CASSETTE II, TAPED, PINKNov 6, 2025MalfunctionSimport1419341-2025-00038
- ACTIVFLO ROUTINE I-TAPED- BLUE 1000Oct 22, 2025MalfunctionXiamen Voke Mold & Plastic Engineer1419341-2025-00036
- ACTIVFLO ROUTINE I-TAPED-YELLOW 1000Jul 22, 2025MalfunctionLeica Biosystems Richmond Inc.1419341-2025-00031
- ACTIVFLO ROUTINE I-TAPED-YELLOW 1000Jun 25, 2025MalfunctionLeica Biosystems Richmond Inc.1419341-2025-00030
- TISSUE-TEK® PARAFORM® CORE BIOPSY CASSETTESApr 17, 2025InjurySakura Finetek Usa, Inc.2083544-2025-00004
- ACTIVFLO ROUTINE I-TAPED- WHITE 1000Feb 5, 2025MalfunctionLeica Biosystems1419341-2025-00022
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
56 firms currently registered for this product code
Cancer Diagnostics, Inc.
Durham, NC, US
Diatrust Medical Co., Ltd.
Nanjing City Jiangsu, CN
Muto Pure Chemicals Co., Ltd.
Tokyo, JP
Vork Technologies (malaysia) Sdn. Bhd.
Senai Johor, MY
Fujian Liao Paper Co., Ltd
Quanzhou Fujian, CN
Les Plastiques Mdj Inc.
Saint-Hubert Quebec, CA
Shanghai Youding International Trade Co., Ltd.
SHANGHAI, CN
Slee Medical Gmbh
Nieder-Olm Rhineland-Palatinate, DE
Guangzhou Four E's Scientific Co., Ltd.
GUANGZHOU Guangdong, CN
Hua Cheng Xin Plastic Mold Co. Ltd.
Shenzhen Guangdong, CN
General Data Healthcare
Cincinnati, OH, US
Simport Scientific Inc.
BELOEIL Quebec, CA
Fa-tech Diagnostics Europe Bv
Duiven Gelderland, NL
Zhejiang Gongdong Medical Technology Co., Ltd
TAIZHOU Zhejiang, CN
Trademark Plastics Inc.
Riverside, CA, US
Sakura Finetek U.s.a., Inc.
TORRANCE, CA, US
S.p.f. Plastics B.v.
Zaltbommel Gelderland, NL
Nextcon International
Sialkot Punjab, PK
Acot Plastics (xiamen) Co., Ltd.
XIAMEN Fujian, CN
Creative Waste Solutions, Inc.
Tualatin, OR, US
Guangzhou Komaspec Mechanical And Electrical Products Manufa
Huashan Town, Huadu District, Guangdong, CN
Leica Biosystems Richmond, Inc.
Richmond, IL, US
Performance Plastics Ltd.
Cincinnati, OH, US
Shandon Diagnostics Limited
RUNCORN Cheshire East, GB
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
510(k) clearances
5 clearances for this product code
- Surgipath Medical Industries, Inc.Sep 16, 1986
K863483 · CASSETTE EMBOSSEER
- Australian Biomedical Corporation , Ltd.Jul 16, 1986
K862457 · LYNX EL MICROSCOPY TISSUE PROCESSOR
- Polymer Technology Corp.Dec 2, 1983
K833857 · MACLEAN-FOGG, TISSUE CASSETTES
- Surgipath Medical Industries, Inc.May 25, 1983
K831334 · TISSUE CASSETTES FOR PROCESSING-EM BED
- Sherwood Medical IndustriesSep 27, 1976
K760623 · LANCER PARAPLAST HISTO PROCESS CASSETTE