Stains, Hematology
FDA product code KQC · Class I (low risk) · 21 CFR 864.1850 · Hematology
9510(k) clearances
0PMA approvals
5recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882873 | Fieldtex HematoxylinKQC · Traditional | Anatech, Ltd. | 07/28/1988SE |
| K852843 | General Diagnostics Coag-A-Mate XCKQC · Traditional | Warner-Lambert Co. | 08/13/1985SE |
| K843619 | Retic-SetKQC · Traditional | R&D Systems, Inc. | 10/30/1984SE |
| K841848 | Retic-SetKQC · Traditional | R&D Systems, Inc. | 05/31/1984SE |
| K792550 | Ponceau S Stain SetKQC · Traditional | Electrophoresis Corp. of America | 01/16/1980SE |
| K792496 | Volu-Sol NMB Reticulocyte StainKQC · Traditional | Volu Sol Medical Industries | 12/31/1979SE |
| K791007 | Stat Diff StainKQC · Traditional | Bioscientific | 08/03/1979SE |
| K760487 | Hemastain Phosphate BufferKQC · Traditional | Geometric Data, Div. Smithkline Corp. | 08/30/1976SE |
| K760485 | Hemastain FixativeKQC · Traditional | Geometric Data, Div. Smithkline Corp. | 08/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2953-2018 Class II | Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex…The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when… | Sysmex America, Inc. | 07/27/2018Terminated |
| Z-0045-2018 Class II | Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood…There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results… | Sysmex America, Inc. | 09/08/2017Completed |
| Z-2770-2016 Class II | Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a…There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results… | Sysmex America Inc | 07/01/2016Terminated |
| Z-0043-2012 | Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals…Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens. | EMD Chemicals Inc. | 04/04/2011Terminated |
| Z-0133-2008 | Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals…Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of… | EMD Chemicals Inc | 07/30/2007Terminated |