Atellica CH Systems Fructosamine — Class II medical device recall Z-0102-2021
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2020-10-21, distributed in CA, DE, MD, NC, NJ, NY, PA. Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared
| Recall number | Z-0102-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2020-09-22 |
| Classified | 2020-10-13 |
| Reported by FDA | 2020-10-21 |
| Distributed | CA, DE, MD, NC, NJ, NY, PA |
| Countries outside the US | AR, AU, BR, CA, CN, CZ, DE, DK, IT, NL, PY, SK, TR, VN |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414595580 |
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.