Atellica CH 930 Analyzer — Class II medical device recall Z-0581-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-12-04, distributed in AL, AR, AZ, CA, CO, DC, FL, GA…. Potential for calibration error resulting in QC failures after the calibration run with QC and patient results
| Recall number | Z-0581-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2019-09-23 |
| Classified | 2019-11-27 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2022-07-06 |
| Distributed | AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, WA, WV |
| Quantity | 1,432 |
| UPC / GTIN / UDI-DI | 00630414002163 |
Product
Atellica CH 930 Analyzer
Reason for recall
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
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-0581-2020. 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.