Home › Device types › GIF
Diluent, Blood Cell
FDA product code GIF · Class 1 · Hematology
130
Registered devices
144
Adverse events
13
Recalls
38
510(k) clearances
Devices with this code
CELLPACK — SYSMEX CORPORATIONUF-Cellpack SF — SYSMEX CORPORATIONCOULTER LH Series Diluent — Beckman Coulter, Inc.ISOFLOW SHEATH FLUID — Beckman Coulter, Inc.Atellica IM Multi-Diluent 1 — Siemens Healthcare Diagnostics Inc.XW pack D — SYSMEX CORPORATIONIMMULITE® 2000 Systems ID1 IgG/IgM Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCARDINAL HEALTH — Cardinal Health 200, LLCCELLPACK-S — SYSMEX CORPORATIONLumipulse G Specimen Diluent 2 — FUJIREBIO INC.CELLPACK — SYSMEX CORPORATIONAtellica IM Multi-Diluent 2 — Siemens Healthcare Diagnostics Inc.Needle Holder — KOROS U.S.A., INC.DxFLEX Sheath Fluid — Beckman Coulter, Inc.CELLSHEATH C — SYSMEX CORPORATIONAtellica IM Multi-Diluent 1 — Siemens Healthcare Diagnostics Inc.IMMULITE® 2000 Systems MD2 Multi-Diluent 2 Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCAST® Stimulation Buffer Basophil — Bühlmann Laboratories AGCOULTER Ac•T 5diff Diluent — Beckman Coulter, Inc.Iris® — BECKMAN COULTER IRELAND INC.Swelab Lumi-D Diluent — Boule Medical ABCELL-DYN — ABBOTT LABORATORIESISOFLOW SHEATH FLUID — Beckman Coulter, Inc.UF II PACK-SED — SYSMEX CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-10 | Beckman Coulter, Inc. | Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. |
| 2023-05-31 | Beckman Coulter, Inc. | Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. |
| 2018-01-24 | Mindray DS USA, Inc. dba Mindray North America | Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system t |
| 2018-01-24 | Mindray DS USA, Inc. dba Mindray North America | Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to |
| 2015-07-22 | Beckman Coulter Inc. | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. |
| 2015-07-22 | Beckman Coulter Inc. | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. |
| 2015-04-13 | Beckman Coulter Inc. | Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The |
| 2014-08-25 | Beckman Coulter Inc. | Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This |
| 2006-12-22 | Abbott Laboratories | Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 400 |
| 2006-04-17 | Abbott Laboratories | High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range. |
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