FDA Device recall Z-1301-2019
Atellica Sample Handler Prime, Material Number 11069001
- FDA Device
- Class II
- terminated
- Published 2019-05-15
On 2019-05-15 the FDA classified a Class II recall of Atellica Sample Handler Prime, Material Number 11069001 by Siemens Healthcare Diagnostics, citing there were multiple issues identified in the system software which required an update.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1301-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-07 |
| Published | 2019-05-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, UT, WA, WV, WY |
Product
Atellica Sample Handler Prime, Material Number 11069001
Reason
There were multiple issues identified in the system software which required an update.
Identifiers
| code_info | UDI: 00630414002026 |
|---|
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-1301-2019%22
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