# FDA recall Z-0466-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-09-07.

## Product

Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745    Product Usage:  Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.

## Reason for recall

There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.

## Distribution

Worldwide - US Nationwide  Distributions    The products were distributed to the following foreign countries:  Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Paraguay, El Salvador, Thailand, Taiwan, Uruguay and South Africa, Austria, Bahamas, Belgium, Czech Republic, Denmark, , France, , Italy, Netherland, Norway , Portugal, Kuwait, Slovenia, Spain, Switzerland, United Kingdom, Qatar,  Republic of Korea, Saudi Arabia, Slovakia, Algeria, Bahrain, Bulgaria, Egypt, , Hungary, Latvia, Lebanon, Lithuania, Macedonia, Nepal, Poland, Romania, Russia Fed, Serbia, Turkey, U.A.E, United Kingdom.

## Key facts

- **Recall number:** Z-0466-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-07
- **Report date:** 2018-11-21
- **Termination date:** 2020-11-16

- **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-0466-2019

## Citation

> AI Analytics. FDA recall Z-0466-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0466-2019. Source: US FDA. Licensed CC0.

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