# FDA recall Z-2290-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2019-07-10.

## Product

IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D);  SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170

## Reason for recall

There is a potential for low discordant progesterone results on a subset of patient samples.  A falsely low progesterone result may lead to the consideration for additional progesterone  supplementation.

## Distribution

Global distribution.  US Nationwide.

## Key facts

- **Recall number:** Z-2290-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-10
- **Report date:** 2019-08-28
- **Termination date:** 2024-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2290-2019

## Citation

> AI Analytics. FDA recall Z-2290-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2290-2019. Source: US FDA. Licensed CC0.

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