Advia® 120/2120/2120i TESTpoint High Control
ADVIA®120/2120/2120i TESTpoint™ High Control
1manufacturer
1catalogue number
3recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Onechipdx Biotech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Specification developer | 2 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JCN |
| Device type | Control, Cell Counter, Normal And Abnormal |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K896154 |
| 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; Handling environment temperature 2 to 8 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10312291 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Para 12 Plus | Streck LLC | 7 |
| STaK-Chex | Streck LLC | 6 |
| Liquichek | Bio-Rad Laboratories Inc. | 5 |
| Cell-DYN | Abbott Laboratories | 2 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 1 |
| Advia® 120/2120/2120i TESTpoint Low Control | Siemens Healthcare Diagnostics Inc | 1 |
| Advia® 120/2120/2120i 3-in-1 TESTpoint High Control | Siemens Healthcare Diagnostics Inc | 1 |
| OLO Control Kit | S.D. Sight Diagnostics, Ltd. | 1 |
| Advia® 120/2120/2120i TESTpoint Normal Control | Siemens Healthcare Diagnostics Inc | 1 |
| Advia® 120/2120/2120i 3-in-1 TESTpoint Normal Control | Siemens Healthcare Diagnostics Inc | 1 |
| Advia® 120/2120/2120i 3-in-1 TESTpoint Low Control | Siemens Healthcare Diagnostics Inc | 1 |
| R & D Systems, Inc. CBC-PIX Hematology Control | Research AND Diagnostic Systems, Inc. | 1 |
Recalls
3 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 |
|---|---|---|---|---|
| 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. | 3,435 units |
| 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. | 4,214 units |
| 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. | 3,266 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.