Enzyme Immunoassay, Tracrolimus
FDA product code MLM · Class II (moderate risk) · 21 CFR 862.1678 · Clinical Chemistry
9510(k) clearances
2PMA approvals
10recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203833 | Tacrolimus Assay KitMLM · Traditional | Shanghai Genext Medical Technology Co., Ltd. | 01/27/2023SE |
| K173857 | Elecsys TacrolimusMLM · Traditional | Roche Diagnostics | 11/06/2018SE |
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC…MLM · Traditional | Siemens Healthcare Diagnostics | 11/04/2015SE |
| K123343 | Thermo Scientific QMS Tacrolimus Assay and CalibratorsMLM · Traditional | Microgenics Corp. | 07/11/2013SE |
| K070820 | Architect Tacrolimus: Model 1L77MLM · Traditional | Fujirebio Diagnostics,Inc. | 08/01/2007SE |
| K063868 | Masstrak Immunosuppressants KitMLM · Traditional | Waters Corporation | 05/25/2007SE |
| K060502 | Dimension Tacr Flex Reagent Cartridge, Model DF107MLM · Traditional | Dade Behring, Inc. | 05/18/2006SE |
| K060385 | Emit 2000 Tacrolimus Assay and Sample Pretreatment ReagentMLM · Traditional | Dade Behring, Inc. | 04/06/2006SE |
| K050206 | Cedia Tacrolimus AssayMLM · Traditional | Microgenics Corp. | 03/15/2005SE |
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2398-2026 Class II | Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795…A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension… | Siemens Healthcare Diagnostics, Inc. | 05/07/2026Open, Classified |
| Z-1258-2023 Class II | Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the…Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and… | Siemens Healthcare Diagnostics, Inc. | 01/30/2023Open, Classified |
| Z-1284-2022 Class II | QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3…Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in… | Microgenics Corporation | 01/20/2022Open, Classified |
| Z-1661-2018 Class II | Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1464-2015 Class II | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The…Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. | Diasorin Inc. | 03/16/2015Terminated |
| Z-1924-2013 Class II | Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107)…Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR… | Siemens Healthcare Diagnostics, Inc. | 07/01/2013Terminated |
| Z-0517-2014 Class II | Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro…Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in… | Siemens Healthcare Diagnostics, Inc. | 04/25/2013Terminated |
| Z-0957-2013 Class II | Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is…Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot… | Siemens Healthcare Diagnostics, Inc. | 11/27/2012Terminated |
| Z-0068-2011 | Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle…There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the… | Abbott Laboratories | 09/07/2010Terminated |
| Z-2407-2010 | Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare…Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in… | Siemens Healthcare Diagnostics, Inc. | 06/15/2010Terminated |