# FDA recall Z-1015-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-02-22.

## Product

IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]

## Reason for recall

Potential for falsely elevated hCG results due to sample carryover in serum and urine  patient samples, as well as quality control samples and adjustors.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, MN, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WI, WY and OUS: 81 countries.

## Key facts

- **Recall number:** Z-1015-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-22
- **Report date:** 2022-05-04

- **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-1015-2022

## Citation

> AI Analytics. FDA recall Z-1015-2022. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1015-2022. Source: US FDA. Licensed CC0.

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