# FDA recall Z-1648-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-07-18.

## Product

Dimension Vista LOCI CA 15-3 Flex reagent cartridge.  In Vitro Diagnostic for the quantitative measurement of CA 15-3.   Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456

## Reason for recall

Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.

## Key facts

- **Recall number:** Z-1648-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-18
- **Report date:** 2022-09-07

- **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-1648-2022

## Citation

> AI Analytics. FDA recall Z-1648-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1648-2022. Source: US FDA. Licensed CC0.

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