Atellica Solution IM1300 Analyzer — Class II medical device recall Z-2404-2020
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2020-07-01, distributed in AL, AZ, CA, CO, CT, DC, FL, GA…. Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample co
| Recall number | Z-2404-2020 |
|---|---|
| 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 | 2020-05-07 |
| Classified | 2020-06-19 |
| Reported by FDA | 2020-07-01 |
| Distributed | 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 |
| Countries outside the US | MX |
| Quantity | 927 |
| UPC / GTIN / UDI-DI | 00630414007960 |
Product
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Reason for recall
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.
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-2404-2020. 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.