Recall Z-2398-2026
- Recall number
- Z-2398-2026
- Event number
- 98985
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Firm FEI
- 2517506
- Product code
- MLM
- Status
- Open, Classified
- Initiated
- 2026-05-07
- Posted
- 2026-06-10
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K150168, K060502, K063868, K060385, K050206, K203833, K123343, K070820, K173857
Product#
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Reason for Recall#
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.