Dimension® Flex® Reagent Cartridge TAC
Dimension Flex reagent cartridge TAC quantitatively measures tacrolimus in human whole blood on the Dimension clinical chemistry system. Results aid management of tacrolimus treatment in…
Dimension Flex reagent cartridge TAC quantitatively measures tacrolimus in human whole blood on the Dimension clinical chemistry system. Results aid management of tacrolimus treatment in kidney and liver transplant patients.
The automated immunoassay uses pretreatment reagents to lyse blood and release tacrolimus from binding proteins. Antibody-enzyme conjugate binds sample drug, while magnetic particles separate bound and unbound components.
Listed Item
Tacrolimus Flex® reagent cartridge, TAC, 80 tests (4 x 20)
Signal Measurement
The separated complex reacts with a substrate to produce a colored product measured at 577 nm with a 700 nm reference. The eight-well cartridge holds the assay reagents. Samples exceeding 20 ng/mL trigger an additional analysis to check for nonspecific signal before a result is reported.
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 | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | MLM |
| Device type | Enzyme Immunoassay, Tracrolimus |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1678 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K150168 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10700795 | 4 | 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 |
| Syva® Emit® 2000 Tacrolimus Assay | Siemens Healthcare Diagnostics Inc | 1 |
| MassTrak™ | Waters Corporation | 1 |
| QMS Tacrolimus Immunoassay | Microgenics Corporation | 1 |
| Alinity-Architect | Abbott Laboratories | 1 |
| Atellica CH Tacr | Siemens Healthcare Diagnostics Inc | 1 |
| Dimension® Flex® reagent cartridge Tacr | Siemens Healthcare Diagnostics Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150168 | 2015-11-04 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2026-05-07 | Class II | Under Investigation by firm | A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. | 2878 units |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2023-01-30 | Class II | Under Investigation by firm | Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient result | 6035 units |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2017-06-29 | Class II | Device Design | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. | 10,067 | 2020-04-23 |
| 2013-07-01 | Class II | Process control | Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the ass | 5423 | 2014-08-26 |
| 2013-04-25 | Class II | Component design/selection | Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results. | 13,751 | 2014-11-12 |
| 2012-11-27 | Class II | Process control | Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing | 2,976 | 2014-08-04 |
| 2010-06-15 | Not classified | Other | Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result. | 4580 Cartons | 2010-12-16 |
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.