Coulter LH Series Diluent
Catalogue number 8547194, listed by Beckman Coulter, Inc., United States, under Diluent, Blood Cell. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
6recalls on this code
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | GIF |
| Device type | Diluent, Blood Cell |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8200 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-31 |
| Record revised | 2025-11-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 30 °C |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8547194 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cell-DYN | Abbott Laboratories | 7 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Cellpack | Sysmex Corporation | 4 |
| Cellpack DST | Sysmex Corporation | 4 |
| Drew Scientific | Drew Scientific, Ltd. | 3 |
| Atellica IM Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| Cellpack DCL | Sysmex Corporation | 3 |
| SP | Cardinal Health 200, LLC | 3 |
| Needle Holder | Koros U.S.A., Inc. | 3 |
| Advia Centaur® Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| UF II Pack-SED | Sysmex Corporation | 2 |
| Cellsheath | Sysmex Corporation | 2 |
Showing 12 of 88. All products under Diluent, Blood Cell
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-11-10 | Class II | Under Investigation by firm | Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. | 76,098 units (US-61843 and OUS-14255) | |
| 2023-05-31 | Class II | Under Investigation by firm | Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. | 335, 448 units | |
| 2015-07-22 | Class II | Nonconforming Material/Component | 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. | 710 units | 2015-12-18 |
| 2015-07-22 | Class II | Nonconforming Material/Component | 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. | 409,042 units (339,545 units in US) | 2015-12-18 |
| 2015-04-13 | Class II | Nonconforming Material/Component | 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 Diluent lots listed in the recall notice may eventually result i | 829,888 units total (659,584 units in US) | 2015-10-01 |
| 2014-08-25 | Class II | Under Investigation by firm | 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 failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cel | 46,050 units total (40,078 units in US) | 2015-02-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.