# FDA recall Z-1675-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-01-02.

## Product

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc

## Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy  Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

## Distribution

Nationwide and Canada, Mexico, and Thailand

## Key facts

- **Recall number:** Z-1675-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-02
- **Report date:** 2018-05-16
- **Termination date:** 2023-02-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1675-2018

## Citation

> AI Analytics. FDA recall Z-1675-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-1675-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*