Advia Centaur® Shbg MCM
SHBG Master Curve Material Set - CENTAUR - CONS
2manufacturers in China registered for this device type
1catalogue number
10510(k) clearances naming this product code
28recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Roche Diagnostics (Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JLW |
| Device type | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083844 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store Upright; Storage environment temperature 2 to 8 °C |
| Distribution end date | 2019-09-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10283086 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atellica IM TSH3-UL | Siemens Healthcare Diagnostics Inc | 4 |
| Elecsys TSH | Roche Diagnostics Gmbh | 4 |
| Advia Centaur® TSH3-UL | Siemens Healthcare Diagnostics Inc | 3 |
| Advia Centaur® TSH | Siemens Healthcare Diagnostics Inc | 3 |
| Atellica IM TSH3-Ultra II | Siemens Healthcare Diagnostics Inc | 3 |
| Free T3, Free T4, TSH Thyroid Panel AccuBind Vast Elisa Test System – 960 Wells | Monobind, Inc. | 3 |
| Architect | Abbott Ireland | 2 |
| Immulite 2000 Third Generation TSH | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Thyrotropin (TSH) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| AccuDiag ™ | Diagnostic Automation, Inc. | 2 |
| Immulite® 2000 Systems TSH Third Generation TSH | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Maglumi 2000 TSH | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
Showing 12 of 87. All products under Radioimmunoassay, Thyroid-Stimulating Hormone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251543 | 2026-02-06 |
| K243570 | 2025-04-25 |
| K233050 | 2024-04-04 |
| K222116 | 2023-07-13 |
| K160647 | 2016-05-31 |
| K151792 | 2015-11-20 |
| K150403 | 2015-05-01 |
| K141999 | 2015-04-22 |
| K083844 | 2009-05-08 |
| K081074 | 2008-05-23 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-04-10 | Class II | Device Design | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. | 22,770 kits | 2016-05-27 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-04-10 | Class II | Device Design | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. | 155,345 kits | 2016-05-27 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2013-05-10 | Class II | Device Design | A rare variant of TSH, identified in a small cluster of patients, is not detected. | 172913 | 2016-05-10 |
Recalls
21 of these are Class II. Class II means a temporary or reversible health consequence. 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 | Closed |
|---|---|---|---|---|---|
| 2022-04-13 | Class II | Under Investigation by firm | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results | 1,566 | |
| 2022-04-13 | Class II | Under Investigation by firm | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results | 2,321 | |
| 2021-05-13 | Class II | Component design/selection | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject t | US: 233 OUS: 233 | |
| 2021-05-13 | Class II | Component design/selection | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject t | US: 123 OUS: 751 | |
| 2020-10-26 | Class II | Under Investigation by firm | Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version tha | US 392 units; OUS 449 units | 2024-04-19 |
| 2020-10-26 | Class II | Under Investigation by firm | Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some o | US: 214 units; OUS: 1082 units | 2024-04-19 |
| 2019-03-07 | Class II | Under Investigation by firm | There were multiple issues identified in the system software which required an update. | 366 | 2020-08-20 |
| 2019-03-07 | Class II | Under Investigation by firm | There were multiple issues identified in the system software which required an update. | 277 | 2020-08-20 |
| 2018-01-02 | Class II | Error in labeling | The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly st | 2023-02-10 | |
| 2018-01-02 | Class II | Error in labeling | The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly st | 2023-02-10 | |
| 2017-12-18 | Class II | Device Design | In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays. | 74,215 | |
| 2017-03-21 | Class II | Under Investigation by firm | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, a | 19, 927.00 | 2018-08-03 |
| 2016-05-26 | Class II | Under Investigation by firm | Eight (8) issues were identified which may affect the results generated by the system software version. | 446 units Total (3 domestically & 443 internationally) | 2018-06-07 |
| 2016-04-28 | Class II | Under Investigation by firm | The ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any | 292 units Total (3 domestically & 289 internationally) | 2018-06-07 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well. | 2256 | 2016-12-13 |
| 2014-04-10 | Class II | Device Design | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. | 8,052 kits | 2016-05-27 |
| 2013-05-10 | Class II | Device Design | A rare variant of TSH, identified in a small cluster of patients, is not detected. | 18584 | 2016-05-10 |
| 2013-05-10 | Class II | Device Design | A rare variant of TSH, identified in a small cluster of patients, is not detected. | 33506 | 2016-05-10 |
| 2013-05-10 | Class II | Device Design | A rare variant of TSH, identified in a small cluster of patients, is not detected. | 51792 | 2016-05-10 |
| 2013-05-10 | Class II | Device Design | A rare variant of TSH, identified in a small cluster of patients, is not detected. | 39763 | 2016-05-10 |
| 2013-05-10 | Class II | Device Design | A rare variant of TSH, identified in a small cluster of patients, is not detected. | 13462 | 2016-05-10 |
| 2012-11-28 | Class III | Nonconforming Material/Component | The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 | Lot 831=19 units (all foreign consignees) and Lot 832=2 unit | 2013-10-28 |
| 2012-11-28 | Class III | Nonconforming Material/Component | The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 | Lot 969=33 units (29 units foreign) Lot 970=7 units (42 unit | 2013-10-28 |
| 2012-11-28 | Class III | Nonconforming Material/Component | The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 | Lot 742= 8 units all foreign consignees) Lot 743=7 units (al | 2013-10-28 |
| 2010-04-12 | Not classified | Other | Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results. | 4187 | 2013-03-19 |
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.