# FDA recall Z-0366-2026

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2025-09-22.

## Product

Assay: IMMULITE 2000 Intact PTH;  Test Code: iPT;  Siemens Material Number (SMN): (1) 10381441, (2) 10381442;  Catalog Number: (1) L2KPP2, (2) L2KPP6;

## Reason for recall

The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems.  The bias is observed in both serum and plasma samples.

## Distribution

Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID, IN, LA, MD, NC, NJ, NY, PA, SC and the countries of Argentina, Australia, Bolivia, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Iran, Israel, Italy, Kosovo, Kuwait, Latvia, Lebanon, Macedonia, Mexico, Nepal, Netherlands, P.R. China, Pakistan, Palestinian Ter, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, U.A.E., Ukraine, Uruguay, Uzbekistan.

## Key facts

- **Recall number:** Z-0366-2026
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-22
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0366-2026

## Citation

> AI Analytics. FDA recall Z-0366-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0366-2026. Source: US FDA. Licensed CC0.

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