Alinity
Alinity i Processing Module, refurbished
3manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | DHA |
| Device type | System, Test, Human Chorionic Gonadotropin |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2025-10-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03R6584 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioSign® hCG card | Princeton BioMeditech Corp. | 5 |
| Architect | Abbott Ireland | 5 |
| BioStrip® P | Princeton BioMeditech Corp. | 4 |
| AccuHome Pregnancy Test | Germaine Laboratories, Inc. | 3 |
| Elecsys HCG Test System | Roche Diagnostics Gmbh | 3 |
| Status hCG card | Princeton BioMeditech Corp. | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Maglumi 2000 HCG/beta-HCG | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
| Access Total BhCG (5th IS) | Beckman Coulter, Inc. | 2 |
| Immulite®/Immulite® 1000 Systems HCG Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Alinity | Abbott Ireland | 2 |
| Immulite® 2000 Systems HCG | Siemens Healthcare Diagnostics Products GmbH | 2 |
Showing 12 of 46. All products under System, Test, Human Chorionic Gonadotropin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230937 | 2023-06-05 |
| K230790 | 2023-05-19 |
| K170317 | 2017-10-23 |
| K983424 | 1998-12-01 |
| K884207 | 1988-12-02 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-11-24 | Class III | Material/Component Contamination | Reaction vessels may contain a potential contaminant that could affect their optical performance. | 70 cases |
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.