Home › Device types › KQC
Stains, Hematology
FDA product code KQC · Class 1 · Hematology
33
Registered devices
6
Adverse events
5
Recalls
9
510(k) clearances
Devices with this code
Ral Diff-Quik Solution II (1 x 2,5L) — R.A.L. DIAGNOSTICSDiff-Quik™ Solution II — Siemens Healthcare Diagnostics Products GmbHCamco — CAMBRIDGE DIAGNOSTIC PRODUCTS INCCamco — CAMBRIDGE DIAGNOSTIC PRODUCTS INCFluoroQuench Acridine Orange/Ethidium Bromide - 500ml — ONE LAMBDA, INC.Ral Diff-Quik Solution I (1 x 2,5L) — R.A.L. DIAGNOSTICSCOULTER TruColor May Grünwald Stain — Beckman Coulter, Inc.COULTER TruColor Wright-Giemsa Stain — Beckman Coulter, Inc.Diff-Quik™ Solution I — Siemens Healthcare Diagnostics Products GmbHDiff-Quik™ Fixative — Siemens Healthcare Diagnostics Products GmbH3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLCFluoroQuench Acridine Orange/Ethidium Bromide - 100ml — ONE LAMBDA, INC.LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) — BONRAYBIO CO., LTD.COULTER TruColor Wright Stain — Beckman Coulter, Inc.COULTER TruColor Wright- Giemsa Stain — Beckman Coulter, Inc.Diff-Quik™ Stain Set — Siemens Healthcare Diagnostics Products GmbHCamco — CAMBRIDGE DIAGNOSTIC PRODUCTS INCCOULTER TruColor Wright Stain Buffer — Beckman Coulter, Inc.COULTER TruColor Wright Stain — Beckman Coulter, Inc.Camco — CAMBRIDGE DIAGNOSTIC PRODUCTS INCCamco — CAMBRIDGE DIAGNOSTIC PRODUCTS INCFluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml — ONE LAMBDA, INC.Ral Diff-Quik EZ-Kit (3 x 100ml) — R.A.L. DIAGNOSTICSFluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 ml — ONE LAMBDA, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-27 | Sysmex America, Inc. | The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT. |
| 2017-09-08 | Sysmex America, Inc. | There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower tha |
| 2016-07-01 | Sysmex America Inc | There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than ex |
| 2011-04-04 | EMD Chemicals Inc. | Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens. |
| 2007-07-30 | EMD Chemicals Inc | Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run a |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.