LH Series Cleaner
LH Series Cleaner (10L)
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 2 to 25 °C |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 721542 | Withdrawn | |
| 721543 | Withdrawn |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.