# K060502: Dimension Tacr Flex Reagent Cartridge, Model DF107

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 18, 2006 after 83 days
- Product code: MLM (Enzyme Immunoassay, Tracrolimus)
- Device class: 2
- Regulation: 21 CFR 862.1678
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P970007 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970007: Imx Tacrolimus II Assay, Abbott Laboratories (1997) Summary page 1.

## Recalls of this device
- Jul 1, 2013 · Class II · Z-1924-2013: 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. False
- Nov 27, 2012 · Class II · Z-0957-2013: 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
- Jun 15, 2010 · Not classified · Z-2407-2010: Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.

## Indications for use
The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure 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 kidney and liver transplant patients.

Source page: https://510kreport.com/device/K060502
Methodology: https://510kreport.com/methodology