Coulter Ac•T 5diff Rinse
COULTER AcT 5diff Rinse 1 L
5manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JCB |
| Device type | Detergent |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| 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 18 to 25 °C |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8547167 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 9 |
| Cell-DYN | Abbott Laboratories | 7 |
| Coulter Clenz Cleaning Agent | Beckman Coulter, Inc. | 5 |
| Surgical Milk | Germiphene Corp. | 4 |
| Drew Scientific | Drew Scientific, Ltd. | 4 |
| ET Foam | Germiphene Corp. | 4 |
| JAS Diagnostics | Drew Scientific, Ltd. | 3 |
| Carolina Liquid Chemistries Corp.® Wash Concentrate ST160 | Carolina Liquid Chemistries | 3 |
| DxU | Beckman Coulter, Inc. | 3 |
| Detergent for Automatic Urine Analyzer | Urit Medical Electronic Co., Ltd. | 3 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 3 |
| Good Vibrations | MicroCare Medical | 3 |
Showing 12 of 56. All products under Detergent
Recalls
2 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 |
|---|---|---|---|---|---|
| 2013-11-08 | Class II | Under Investigation by firm | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell di | 768 units total (6 units in US) | 2014-12-25 |
| 2013-11-08 | Class II | Under Investigation by firm | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell di | 12,924 units total (9,733 units in US) | 2014-12-25 |
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.