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RANSOD DILUENT (RANSOD DIL)
RANDOX LABORATORIES LIMITED · Model SD124 · UDI-DI 05055273206142
GIF
Prescription
10
510(k) clearances
144
Adverse events
13
Recalls
54
Facilities
Description
This is required for the dilution of heparinized or EDTA whole blood samples for use with the Randox Ransod Reagent.
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.