Home › Device types › GGK
Products, Red-Cell Lysing Products
FDA product code GGK · Class 1 · Hematology
125
Registered devices
78
Adverse events
7
Recalls
29
510(k) clearances
Devices with this code
Drew Scientific — DREW SCIENTIFIC, INC.Swelab Lumi-L2 Lyse — Boule Medical ABDrew Scientific — DREW SCIENTIFIC, INC.COULTER HmX Pak Reagent Kit — Beckman Coulter, Inc.COULTER Ac•T 5diff Hgb Lyse — Beckman Coulter, Inc.CELL-DYN — ABBOTT LABORATORIESCELL-DYN — ABBOTT LABORATORIESCELL-DYN — ABBOTT LABORATORIESBeckmancoulter — IMMUNOTECHIntraStain — AGILENT TECHNOLOGIES SINGAPORE PTE LTDABX LEUCODIFF 1L — HORIBA ABX SASCOULTER Lyse S III diff Lytic Reagent — Beckman Coulter, Inc.STROMATOLYSER-4DS — SYSMEX CORPORATIONABX LYSEBIO (1L) — HORIBA ABX SASCOULTER LH Series Retic Pak Reagent Kit — Beckman Coulter, Inc.MINILYSEBIO (1L) — HORIBA ABX SASAtellica HEMA HGB — Siemens Healthcare Diagnostics Inc.Medonic M51-L2 Lyse — Boule Medical ABM-5LEO(II) Lyse — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.SULFOLYSER — SYSMEX CORPORATIONABX MINILYSE LMG (1L) — HORIBA ABX SASCELL-DYN — ABBOTT LABORATORIESCOULTER HmX Pak Regent Kit — Beckman Coulter, Inc.Diatro•Lyse-5P — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2011-07-11 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter identified unexpected high particle counts in the lots of DxH Cell Lyse listed. These lots may generate high ba |
| 2011-04-11 | Sysmex America, Inc. | The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background co |
| 2011-04-08 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A |
| 2010-12-28 | Beckman Coulter Inc. | The recall was initiated by Beckman Coulter because the COULTER LYSE III diff Lytic Reagent Lot number 101554F was released for distribution to customers betwee |
| 2009-06-23 | Sysmex America, Inc. | The affected lots of Stromatolyser-IM lysing reagent was found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background cou |
| 2007-12-19 | Abbott Laboratories | Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination. |
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