# FDA recall Z-2975-2026

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2026-07-13.

## Product

Syva EMIT 2000 Quinidine Assay  REF: 4Q019UL  Contents: 1x28 mL, 1x14mL

## Reason for recall

Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

## Distribution

Worldwide - US Nationwide distribution in the state of CA and the country of Italy.

## Key facts

- **Recall number:** Z-2975-2026
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-13
- **Report date:** 2026-08-26

- **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-2975-2026

## Citation

> MORVS. FDA recall Z-2975-2026. Retrieved 2026-10-25 from https://api.morvs.ai/recall/Z-2975-2026. Source: US FDA. Licensed CC0.

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