# FDA recall Z-3103-2024

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2024-07-26.

## Product

ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers  SMN: 10491379       SMN: 11206239

## Reason for recall

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample  results above a concentration of 110 U/mL.

## Distribution

Worldwide - US Nationwide distribution

## Key facts

- **Recall number:** Z-3103-2024
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-26
- **Report date:** 2024-09-18

- **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-3103-2024

## Citation

> AI Analytics. FDA recall Z-3103-2024. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3103-2024. Source: US FDA. Licensed CC0.

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