Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and… recallZ-0940-2014 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 6, 2013
Class II Terminated All recalls posted in February 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
The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
FDA root cause category: Software design
What the company is doing
Siemens sent an Urgent Medical Device Correct letter, dated November 6, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain the recall notification letter with their laboratory records and forward to those who may have received the affected product.
Recall details
- Recall number
- Z-0940-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 6, 2013
- Posted by the FDA
- Feb 9, 2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 3759
- Product code
- JJE
- FDA submissions
- K990346
- Distribution
- Worldwide Distribution and USA Nationwide.
Product description
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.
Code information (models, lots, serial numbers)
ADVIA 1200 V2.00 - 10386841 ADVIA 1200 V2.01 - 10469445 ADVIA 1650 V3.52 - 10318424 ADVIA 1650 V4.01 - 10285281 ADVIA 1800 V2.01 - 10639244 ADVIA 2400 V4.01 - 10639265
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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