# FDA recall Z-1820-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-08-11.

## Product

IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)  Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)

## Reason for recall

An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may  lead to a delayed follow up of patients with clinical autoimmune thyroid

## Distribution

Worldwide Distribution: US (nationwide) to states of: FL                   IN                   MA                   MI                   NH                   NJ                   NY                   OH                   TX                   UT                    and OUS (Foreign) countries of: Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ P.R.¿China¿¿¿¿¿ Singapore¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿

## Key facts

- **Recall number:** Z-1820-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-11
- **Report date:** 2022-10-05

- **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-1820-2022

## Citation

> AI Analytics. FDA recall Z-1820-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1820-2022. Source: US FDA. Licensed CC0.

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