# FDA recall Z-2398-2026

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2026-05-07.

## 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.

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Brazil, Croatia, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Pakistan, Poland, Saudi Arabia, Spain, South Africa, Sri Lanka, Turkey, United Arab Emirates.

## Key facts

- **Recall number:** Z-2398-2026
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-07
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2398-2026

## Citation

> MORVS. FDA recall Z-2398-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2398-2026. Source: US FDA. Licensed CC0.

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