Official recall notice
FDA DeviceClass IINotable
FDA Recall: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoass
- Recall date
- 2026-06-17
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Recommended action
What to do
2878 units
Product description
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.