Atellica CH Fructosamine — Class II medical device recall Z-0930-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-04-20, distributed nationwide. Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality contro
| Recall number | Z-0930-2022 |
|---|---|
| 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 | 2022-02-09 |
| Classified | 2022-04-14 |
| Reported by FDA | 2022-04-20 |
| Distributed | Nationwide (US) |
| Quantity | 199 |
| UPC / GTIN / UDI-DI | 00630414595580 |
| Lot numbers | 211359, 211451 |
Product
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Reason for recall
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0930-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.