# FDA recall Z-2881-2026

> **Siemens Healthcare Diagnostics, Inc.** · Class III · device recall initiated 2026-06-26.

## Product

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls  SMN 10445390  Catalog No. 7C219UL

## Reason for recall

out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

## Distribution

Worldwide - US Nationwide distribution in the states CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.

## Key facts

- **Recall number:** Z-2881-2026
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-26
- **Report date:** 2026-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2881-2026

## Citation

> AI Analytics. FDA recall Z-2881-2026. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-2881-2026. Source: US FDA. Licensed CC0.

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