Atellica CH B2M
ß2-Microglobulin (B2M) Atellica CH - RGT 400T
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Shandong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JZG |
| Device type | System, Test, Beta-2-Microglobulin Immunological |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5630 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K110874 |
| Record published | 2017-12-22 |
| Record revised | 2022-10-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11097635 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 11 |
| Tinaquant 2Microglobulin | Roche Diagnostics Gmbh | 3 |
| Tina-quant ß2-Microglobulin | Roche Diagnostics Gmbh | 2 |
| Immulite/Immulite 1000 Systems Beta-2-Microglobulin Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 2 |
| B2Microglobulin (B2M) | Randox Laboratories Limited | 2 |
| Advia® Chemistry B2M ß2-Microglobulin Reagents | Siemens Healthcare Diagnostics Inc | 1 |
| N Latex ß2-Microglobulin | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Optilite® Beta-2 Microglobulin Kit | The Binding Site Group Ltd. | 1 |
| N a1-Microglobulin Kit | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Dimension Vista® ß2-Microglobulin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Optilite Beta 2 Microglobulin Urine Kit | The Binding Site Group Ltd. | 1 |
| Beta-2 Microglobulin Elisa | American Laboratory Products Company | 1 |
Showing 12 of 32. All products under System, Test, Beta-2-Microglobulin Immunological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110874 | 2012-01-20 |
| K083463 | 2009-03-13 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | UDI-DI | 2024-10-21 | Class II | Under Investigation by firm | Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent. | 11330 units | |
| Siemens Healthcare Diagnostics Inc | UDI-DI | 2021-12-01 | Class II | Under Investigation by firm | 2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to | US: 46 units OUS: 794 units | 2023-07-07 |
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 |
|---|---|---|---|---|---|
| 2015-11-03 | Class II | Nonconforming Material/Component | Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer | 1637 units. | 2017-01-13 |
| 2015-07-23 | Class II | Environmental control | customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin resul | Total 1655 units | 2017-03-24 |
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.