# FDA recall Z-3065-2024

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2024-07-30.

## Product

Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

## Reason for recall

During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.

## Distribution

Domestic: Nationwide Distribution.  International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.

## Key facts

- **Recall number:** Z-3065-2024
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-30
- **Report date:** 2024-09-18

- **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-3065-2024

## Citation

> AI Analytics. FDA recall Z-3065-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3065-2024. Source: US FDA. Licensed CC0.

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