Siemens IMMULITE 2000 Immunoassay System — Class II medical device recall Z-2469-2020
Terminated recall by Siemens Healthcare Diagnostics Inc., reported 2020-07-08, distributed nationwide. Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially
| Recall number | Z-2469-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc., Flanders, NJ, United States |
| Recall initiated | 2020-05-15 |
| Classified | 2020-06-29 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2022-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,555 units |
| Reason classes | packaging |
| Serial numbers | B0058 |
Product
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
Reason for recall
Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard
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-2469-2020. 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.