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CELLPACK
SYSMEX CORPORATION · Model 88408915 · UDI-DI 04987562020171
GIF
Prescription
10
510(k) clearances
144
Adverse events
13
Recalls
54
Facilities
Description
CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
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 to produce an elevate |
| 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 produce an elevated |
| 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 use of the DxH Dilu |
| 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 will result in faile |
| 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 4000, Ruby and Sapphire |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.