Alinity-Architect
Transplant Pretreatment Tubes
1manufacturer
1catalogue number
2recalls on this code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Yunze Biotechnology Co., Ltd. | Minhang Disctrict | Shanghai | Manufacturer | 1 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | MLM |
| Device type | Enzyme Immunoassay, Tracrolimus |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1678 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-06-14 |
| Record revised | 2025-07-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 01P0603 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Ireland Diagnostics | 2 |
| Elecsys Tacrolimus | Roche Diagnostics Gmbh | 2 |
| Alinity | Abbott Ireland Diagnostics | 2 |
| Dimension® Flex® reagent cartridge TAC | Siemens Healthcare Diagnostics Inc | 1 |
| Syva® Emit® 2000 Tacrolimus Assay | Siemens Healthcare Diagnostics Inc | 1 |
| MassTrak™ | Waters Corporation | 1 |
| QMS Tacrolimus Immunoassay | Microgenics Corporation | 1 |
| Atellica CH Tacr | Siemens Healthcare Diagnostics Inc | 1 |
| Dimension® Flex® reagent cartridge Tacr | Siemens Healthcare Diagnostics Inc | 1 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-09-07 | Not classified | Other | There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode. | 1,995 kits | 2011-05-13 |
| 2003-11-13 | Not classified | Other | Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances. | not lot specific | 2004-10-29 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P970007 | 2002-09-05 | IMX TACROLIMUS II | Abbott Laboratories |
| P970025 | 1999-04-27 | PRO-TRAC II TACROLIMUS ELISA KIT | Diasorin Inc. |
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.