# FDA recall Z-0102-2021

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-09-22.

## Product

Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems  Siemens Material Number (SMN): 11097637

## Reason for recall

Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

## Distribution

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## Key facts

- **Recall number:** Z-0102-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-22
- **Report date:** 2020-10-21

- **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-0102-2021

## Citation

> AI Analytics. FDA recall Z-0102-2021. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0102-2021. Source: US FDA. Licensed CC0.

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