FDA Device recall Z-2404-2020
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
- FDA Device
- Class II
- ongoing
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960 by Siemens Healthcare Diagnostics, citing insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2404-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-05-07 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
Product
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Reason
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.
Identifiers
| code_info | Atellica Tube Top Sample Cups, 1 mL, SMN 11069061; Atellica Tube Top Sample Cups, 2 mL, SMN 11069062; Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2404-2020%22
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