ADVIA 1200 System Software: 1) V2.00 recall: Software Issue
ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement…
Why was ADVIA 1200 System Software: 1) V2.00 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Codes: 1) 10386841, 2) 10469445
- Product
- ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement…
- Recalling firm
- Siemens Healthcare Diagnostics
- Quantity
- 625 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
- Recall date
- November 27, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)