# FDA recall Z-0134-2021

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-08-25.

## Product

Siemens Dimension Vista  Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma    Catalog Number: K2115, SMN# 10642444

## Reason for recall

Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L).  The low outlier results are generated from the last five (5) tests of the well

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria, Belgium, Bahamas, Czech Republic, Denmark, France, Germany, Italy, Japan, Korea, Netherlands, Norway, New Zealand, Portugal, Slovakia, Slovenia, Spain, Switzerland.

## Key facts

- **Recall number:** Z-0134-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-25
- **Report date:** 2020-10-28
- **Termination date:** 2023-05-04

- **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-0134-2021

## Citation

> AI Analytics. FDA recall Z-0134-2021. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0134-2021. Source: US FDA. Licensed CC0.

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