ADVIA 1650 System Software: 1) V4.01, 2) V3.52 recallZ-0344-2014 · Siemens Healthcare Diagnostics · initiated Sep 3, 2013
Class II Terminated All recalls posted in November 2013
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 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
Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
FDA root cause category: Software design
What the company is doing
On September 3, 2013, Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice for the ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems due to a software issue. The software issue has caused the Chemistry Systems to generate reports without error flags. Notices were sent to domestic customers via U.S. and outside the US the distribution is determined at the country level. The customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue at 877-229-3711 (prompt 18).
Recall details
- Recall number
- Z-0344-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 3, 2013
- Posted by the FDA
- Nov 18, 2013
- Recalling firm
- Siemens Healthcare Diagnostics
- Quantity
- 892 units
- Product code
- JGS
- FDA submissions
- K990346
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
Product description
ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Code information (models, lots, serial numbers)
Product Codes: 1) 10318424, 2) 10285281
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
Other products in the same recall event
The FDA groups related products into one recall event (event 66069).
- Z-0343-2014 · TerminatedADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therape…
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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