Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems recallZ-0800-2014 · Siemens Healthcare Diagnostics, Inc. · initiated Dec 17, 2013
Class II Terminated All recalls posted in January 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
The distribution of the Urgent Medical Device Correction letter scheduled to begin on December 17, 2013. x Field service personnel will be notified of the Urgent Medical Device Correction Letter via the Siemens Knowledge Base, as well as information regarding placing labels on the customer system to remind the customer that ///// is not a reportable result. x The Customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue. x Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction.
Recall details
- Recall number
- Z-0800-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 17, 2013
- Posted by the FDA
- Jan 21, 2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1563
- Product code
- JJE
- FDA submissions
- K990346
- Distribution
- Worldwide Distribution. USA nationwide and the country of Canada.
Product description
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
Code information (models, lots, serial numbers)
ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01
Other devices under the same FDA submission
2 devices cleared under K990346 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA® Chemistry XPT System 10723034Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall174 reports
- ADVIA® 1800 Analyzer 10315183Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE150 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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