Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems — Class II medical device recall Z-0800-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-01-29, distributed nationwide. An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calc
| Recall number | Z-0800-2014 |
|---|---|
| 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 | 2013-12-17 |
| Classified | 2014-01-21 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,563 |
| Reason classes | software |
Product
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
Reason for recall
An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.
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-0800-2014. 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.