Stain, Papanicolau
Hematology · 21 CFR 864.1850
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Richard-Allan Scientific CompanyTerminatedMar 11, 2015
Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-
The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain.
Z-1264-2015 · View FDA record ↗ - EMD Chemicals IncTerminatedMar 26, 2003
Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86.
Difficulty in reading slides due to the stain is much greener than normal.
Z-0685-03 · View FDA record ↗
Registered firms
30 firms currently registered for this product code
Volusol
Tooele, UT, US
Sigma-aldrich Corp.
Saint Louis, MO, US
E K Industries, Inc.
JOLIET, IL, US
Ricca Chemical Company Llc
POCOMOKE CITY, MD, US
Zhejiang Gene Science Co., Ltd
shaoxing Zhejiang, CN
Wuhan Landing Intelligence Medical Co.,ltd
Wuhan Hubei, CN
Slmp Llc D.b.a. Statlab Medical Products
McKinney, TX, US
Eng Scientific Llc
New Brunswick, NJ, US
Ricca Chemical Company Llc
ARLINGTON, TX, US
Chaptec America
Montreal Quebec, CA
Leica Biosystems Richmond, Inc.
Richmond, IL, US
Medical Chemical Corporation
TORRANCE, CA, US
Transene Company, Inc.
DANVERS, MA, US
Ssn Solutions
Henrico, VA, US
Hologic, Inc.
LONDONDERRY, NH, US
Ethos Biosciences, Inc.
Logan Township, NJ, US
Statlab Distribution Center
McKinney, TX, US
Hologic, Inc.
Marlborough, MA, US
Hangzhou Healthsky Biotechnology Co., Ltd.
Hangzhou City Zhejiang, CN
Ricca Chemical Company Llc
BATESVILLE, IN, US
Sigma-aldrich Manufacturing, Llc-h&h
Saint Louis, MO, US
Azer Scientific, Inc.
Morgantown, PA, US
Biogenex Laboratories Inc.
Fremont, CA, US
Noul Co., Ltd.
Yongin Si Gyeonggi, KR
Jinan Babio Biotechnology Co.,ltd.
Jinan City Shandong, CN
510(k) clearances
15 clearances for this product code
- Accra Laboratories, Inc.Oct 2, 1984
K843427 · GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
- E K Ind., Inc.Sep 11, 1984
K842735 · PAP STAIN EA-65
- E K Ind., Inc.Sep 11, 1984
K842739 · PAP STAIN, EA-36
- E K Ind., Inc.Aug 17, 1984
K842738 · PAP STAIN EA-50
- E K Ind., Inc.Aug 17, 1984
K842736 · PAP STAIN, OG-6
- Sigma Chemical Co.Feb 17, 1984
K840054 · PAPANICOLAOU STAIN SYS HT40
- Volu Sol Medical IndustriesAug 3, 1982
K822035 · VOLU-SOL GILLS EA
- SurgipathFeb 4, 1982
K820027 · MODIFIED EA 50