Home › Device types › MLM
Enzyme Immunoassay, Tracrolimus
FDA product code MLM · Class 2 · Clinical Chemistry
16
Registered devices
327
Adverse events
12
Recalls
9
510(k) clearances
Devices with this code
Dimension® Flex® reagent cartridge TAC — Siemens Healthcare Diagnostics Inc.Dimension® Flex® reagent cartridge TACR — Siemens Healthcare Diagnostics Inc.Elecsys Tacrolimus — Roche Diagnostics GmbHAlinity — Abbott Ireland DiagnosticsQMS Tacrolimus Immunoassay — Microgenics CorporationARCHITECT — Abbott Ireland DiagnosticsAtellica CH TACR — Siemens Healthcare Diagnostics Inc.MassTrak™ — WATERS TECHNOLOGIES CORPORATIONARCHITECT — Abbott Ireland DiagnosticsAlinity-Architect — ABBOTT LABORATORIESSyva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESSyva® Emit® 2000 Tacrolimus Assay — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsElecsys Tacrolimus — Roche Diagnostics GmbHAlinity — Abbott Ireland Diagnostics
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-07 | Siemens Healthcare Diagnostics, Inc. | A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. |
| 2023-01-30 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lot |
| 2022-01-20 | Microgenics Corporation | Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when us |
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine |
| 2015-03-16 | Diasorin Inc. | Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. |
| 2013-07-01 | Siemens Healthcare Diagnostics, Inc. | Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its link |
| 2013-04-25 | Siemens Healthcare Diagnostics, Inc. | Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results. |
| 2012-11-27 | Siemens Healthcare Diagnostics, Inc. | Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not e |
| 2010-09-07 | Abbott Laboratories | There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode. |
| 2010-06-15 | Siemens Healthcare Diagnostics, Inc. | Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.