CLASS II Device recall · Reported 27 Nov 2013 · FDA Enforcement Report
Advia 1650 System recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Advia 1650 System, distributed nationwide in the US. The recall was initiated on 3 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0344-2014
- FDA event ID
- 66069
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Sep 2013
- FDA classified
- 18 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 3 Sep 2013 | Recall initiated by company | |
| 18 Nov 2013 | Classified by FDA | +76 days |
| 27 Nov 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
Questions about this recall
Why was it 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.
Which lots are affected?
Product Codes: 1) 10318424, 2) 10285281
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 66069| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia 1200 System recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Advia 1800 System recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Advia 2400 System recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Device Malfunction | Nationwide |
More recalls from Siemens Healthcare Diagnostics
All 694| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS III | Syva Emit Disopyramide Assay Enzyme Immunoassay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Atellica CH Urine Albumin recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS III | Syva Emit tox Serum Tricyclic Antidepressant recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |