FDA Device recall Z-0581-2020
Atellica CH 930 Analyzer
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics, citing potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0581-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-23 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AL, AR, AZ, CA, CO, DC, DE, 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 |
Product
Atellica CH 930 Analyzer
Reason
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Identifiers
| code_info | SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0581-2020%22
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