FDA Device recall Z-0800-2014
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems
- FDA Device
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0800-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-17 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
Reason
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.
Identifiers
| code_info | ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0800-2014%22
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