Advia® 120/2120/2120i SETpoint
ADVIA®120/2120/2120i SETpoint™
2manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jilin (1), Guangdong (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 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | KRZ |
| Device type | Calibrator For Hemoglobin And Hematocrit Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8165 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K840261 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from freezing; Storage environment temperature 2 to 8 °C; Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10312285 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CDS Hematology Calibrator | Clinical Diagnostic Solutions, Inc. | 2 |
| Variant II Hemoglobin A1c | Bio-Rad Laboratories Inc. | 2 |
| Cal-Chex | Streck LLC | 2 |
| Boule Cal | Clinical Diagnostic Solutions, Inc. | 1 |
| Variant II Turbo Link | Bio-Rad Laboratories Inc. | 1 |
| Architect | Abbott Laboratories | 1 |
| Advia® 360/560 Calibrator | Siemens Healthcare Diagnostics Inc | 1 |
| Cell-DYN | Abbott Laboratories | 1 |
| Cfas HbA1c | Roche Diagnostics Gmbh | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2025-06-04 | Class II | Under Investigation by firm | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. | 2,020 units |
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.