510(k) · Cleared

Recalled · Class II · 2026

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

K150168510(k) TraditionalCleared Nov 4, 2015282-day reviewClass II21 CFR 862.1678Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Healthcare Diagnostics · MLM Enzyme Immunoassay, Tracrolimus

Cleared on Nov 4, 2015 as substantially equivalent to K070820 (Fujirebio Diagnostics,Inc., 2007) and 1 other predicate after a 282-day review. Its family tree reaches back 2 generations to 1997. It has been recalled 2 times.

Decided: Nov 4, 2015
Review: 282 days
Class: Class II
Product code: MLM
Recalls: 2
Predicates: 2

Its longest line of descent runs back 2 generations to P970007 (1997). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backP970007 Imx Tacrolimus II AssayAbbott Laboratories · 1997 · Recalled
1 generation backK060503 Dimension Tacr Calibrator, Model DC107Dade Behring, Inc. · 2006
This deviceK150168 Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension…Siemens Healthcare Diagnostics · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	P970007	Imx Tacrolimus II Assay	Abbott Laboratories	1997	2
−1	K060503	Dimension Tacr Calibrator, Model DC107	Dade Behring, Inc.	2006	—
0 (this device)	K150168	Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus…	Siemens Healthcare Diagnostics	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K150168, 1997–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MLM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MLM device

#1 K203833 Tacrolimus Assay Kitscore 5.1 · 2 generations · no Class I recall

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K070820	Architect Tacrolimus: Model 1L77 Summary page 4 …Secondary (21CFR§862.1150) Regulatory Class: II Product Code: JIT 3. Predicate Device Abbott® ARCHITECT Tacrolimus Test System - k070820 Dimension® Tacrolimus Calibrator – k060503 Reference Device: LC/MS –MS Assay for Tacrolimus 4. Guidance Document(…	Fujirebio Diagnostics,Inc.	2007	1
*	K060503	Dimension Tacr Calibrator, Model DC107 Summary page 4 …ss: II Product Code: JIT 3. Predicate Device Abbott® ARCHITECT Tacrolimus Test System - k070820 Dimension® Tacrolimus Calibrator – k060503 Reference Device: LC/MS –MS Assay for Tacrolimus 4. Guidance Document(s): “Class II Special Controls Guidance D…	Dade Behring, Inc.	2006	—

Also cleared against K070820: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 7, 2026	Class II	Z-2398-2026	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.
Jan 30, 2023	Class II	Z-1258-2023	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…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
2 of the 3 ancestors have a recall of any class.
3 other devices also cite its predicate K070820.

How does its category compare?

All MLM devices

MLM Enzyme Immunoassay, Tracrolimus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MLM

1in 2023

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLM

Too few MLM 510(k)s in any year since 2007 to give a median.

Recalls per year · MLM

1in 2013

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MLM

8in 2025

2007high 75 (2013) · low 0 (2008)2025

MAUDE reports naming product code MLM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	4
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	2	5
2011	0	—	0	4
2012	0	—	1	31
2013	1	—	1	75
2014	0	—	0	6
2015	1	—	0	1
2016	0	—	0	2
2017	0	—	0	2
2018	1	—	0	26
2019	0	—	0	7
2020	0	—	0	4
2021	0	—	0	1
2022	0	—	0	23
2023	1	—	0	54
2024	0	—	0	62
2025	0	—	0	8
2026	0	—	1	—

What is it indicated for?

The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients.

The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150168 · printed Nov 5, 2026

Cite this page

510(k) Report. “K150168: Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150168

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026