Siemens ADVIA Chemistry Systems models 1200 — Class II medical device recall Z-0940-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-02-19, distributed nationwide. The ADVIA Chemistry software systems using certain software versions allows the system to automatically run as
| Recall number | Z-0940-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2013-11-06 |
| Classified | 2014-02-08 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2015-08-10 |
| Distributed | Nationwide (US) |
| Quantity | 3,759 |
| Reason classes | potency, software |
| Model numbers | 1200, 1650, 1800, 2400 |
Product
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Reason for recall
The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
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-0940-2014. 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.