# FDA recall Z-2966-2026

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

## Product

Siemens Healthineers  Immulite 2000 Systems SYP Syphilis Screen  REF(s):L2kSY2/10489085; L2KSY6/10488319  IVD, RxOnly

## Reason for recall

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, NJ, NY  and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿

## Key facts

- **Recall number:** Z-2966-2026
- **Recalling firm:** Siemens Healthcare Diagnostics Products Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-13
- **Report date:** 2026-08-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Caernarfon, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2966-2026

## Citation

> MORVS. FDA recall Z-2966-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2966-2026. Source: US FDA. Licensed CC0.

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