# FDA recall Z-0089-2023

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-08-24.

## Product

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD  Siemens Material Number (SMN): 10464340	  Catalog Number: K3048A

## Reason for recall

Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an  Abnormal Reaction  [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.

## Distribution

Nationwide Foreign: Canada

## Key facts

- **Recall number:** Z-0089-2023
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-24
- **Report date:** 2022-10-26

- **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-0089-2023

## Citation

> AI Analytics. FDA recall Z-0089-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0089-2023. Source: US FDA. Licensed CC0.

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