[Recalled] 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. — Siemens Healthcare Diag
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | 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. |
|---|---|
| Brand / manufacturer | Siemens Healthcare Diagnostics |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0344-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 September 2013 |
| EAN / barcode | 10318424 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Siemens Healthcare Diagnostics
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.