Architect
ARCHITECT STAT Troponin-I Reagent Kit
1manufacturer
15catalogue numbers in this listing
6510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K040879 |
| Record published | 2016-09-09 |
| Record revised | 2024-10-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature up to 29 °C |
| Distribution end date | 2022-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5P84-10 | In distribution | |
| 06K4904 | In distribution | |
| 2K41-27 | In distribution | |
| 8G63-21 | In distribution | |
| 05P8302 | In distribution | |
| 2K48-10 | In distribution | |
| 8K28-02 | In distribution | |
| 8K28-11 | In distribution | |
| 05P8411 | In distribution | |
| 2K41-01 | In distribution | |
| 3L53-10 | Withdrawn | |
| 2K44-10 | Withdrawn | |
| 2K91-29 | Withdrawn | |
| 2K91-01 | Withdrawn | |
| 2K44-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 39 |
| Exact Diagnostics | Exact Diagnostics | 30 |
| Architect | Abbott Medical | 26 |
| Architect | Abbott Ireland | 24 |
| Alinity | Abbott Medical | 18 |
| Alinity | Abbott Ireland | 16 |
| Architect | Abbott Ireland Diagnostics | 11 |
| Alinity | Abbott Ireland Diagnostics | 11 |
| JAS Diagnostics | Drew Scientific, Ltd. | 10 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 8 |
| AU | Beckman Coulter, Inc. | 6 |
| Fluid Pack | Diamond Diagnostics Inc. | 5 |
Showing 12 of 391. All products under Calibrator, Secondary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170160 | 2017-02-15 |
| K151566 | 2015-07-10 |
| K111023 | 2011-06-10 |
| K053330 | 2005-12-16 |
| K032458 | 2003-10-06 |
| K781423 | 1978-08-31 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Abbott Laboratories | UDI-DI | 2022-07-26 | Class II | Under Investigation by firm | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. | 2451 kits of 100 tests | |
| Abbott Laboratories | UDI-DI | 2019-05-24 | Class III | Under Investigation by firm | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. | 5,483 units | 2021-04-01 |
| Abbott Laboratories | UDI-DI | 2019-05-24 | Class III | Under Investigation by firm | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. | 6,623 units | 2021-04-01 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2020-04-01 | Class III | Employee error | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained. | 65 kits total | 2020-09-01 |
| 2019-05-22 | Class II | Under Investigation by firm | Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a b | 198 Kits | 2021-01-22 |
| 2019-04-09 | Class III | Under Investigation by firm | Devices were delivered without the required dry ice. | 1 unit | 2019-12-20 |
| 2019-04-09 | Class III | Under Investigation by firm | Devices were delivered without the required dry ice. | 1 unit | 2019-12-20 |
| 2019-04-09 | Class III | Under Investigation by firm | Devices were delivered without the required dry ice. | 1 unit | 2019-12-20 |
| 2019-04-09 | Class III | Under Investigation by firm | Devices were delivered without the required dry ice. | 3 units | 2019-12-20 |
| 2019-04-09 | Class III | Under Investigation by firm | Devices were delivered without the required dry ice. | 2 units | 2019-12-20 |
| 2019-04-09 | Class III | Under Investigation by firm | Devices were delivered without the required dry ice. | 2 units | 2019-12-20 |
| 2014-02-12 | Class II | Under Investigation by firm | Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to tho | 7,780 calibrator kits | 2015-05-22 |
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.