# FDA recall Z-0440-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2021-12-01.

## Product

Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma  Siemens Material Number (SMN): 11097635

## Reason for recall

¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, CO,  MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Ecuador, France, Germany, Greece, India, Iran, Israel, Italy, Japan, Mexico, Morocco, Oman, P.R. China, Pakistan, Philippines, Portugal, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, Uruguay.

## Key facts

- **Recall number:** Z-0440-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-01
- **Report date:** 2022-01-05
- **Termination date:** 2023-07-07

- **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-0440-2022

## Citation

> AI Analytics. FDA recall Z-0440-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0440-2022. Source: US FDA. Licensed CC0.

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