Home › Device types › GGK
Products, Red-Cell Lysing Products
FDA product code GGK · Class 1 · Hematology
127
Registered devices
78
Adverse events
7
Recalls
29
510(k) clearances
Devices with this code
ZAPR™ — Incell Corporation, LLCABX LYSEBIO (0.4L) — HORIBA ABX SASXW pack L — SYSMEX CORPORATIONABX BASOLYSE — HORIBA ABX SASDiatro•Lyse-5P — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagCELL-DYN — ABBOTT LABORATORIESLYSERCELL WDF — SYSMEX CORPORATIONABX ALPHALYSE (0.4L) — HORIBA ABX SASDrew Scientific — DREW SCIENTIFIC, INC.Atellica HEMA Baso — Siemens Healthcare Diagnostics Inc.STROMATOLYSER-4DS — SYSMEX CORPORATIONAlinity — ABBOTT LABORATORIESM-5LEO(I) Lyse — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CELL-DYN — ABBOTT LABORATORIESCal-Lyse™ Lysing Solution 1000 Tests — LIFE TECHNOLOGIES CORPORATIONM-5LEO(II) Lyse — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.COULTER LH Series Retic Pak Reagent Kit — Beckman Coulter, Inc.SULFOLYSER — SYSMEX CORPORATIONIMMUNOPREP REAGENT WHOLE BLOOD LYSING — Beckman Coulter, Inc.COULTER Ac•T 5diff Hgb Lyse — Beckman Coulter, Inc.STROMATOLYSER-4DL — SYSMEX CORPORATIONDxH 500 Series Lyse — BECKMAN COULTER IRELAND INC.COULTER Lyse S III diff Lytic Reagent — Beckman Coulter, Inc.M-53LH LYSE — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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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