ADVIA Chemistry XPT System recall: Software Issue
ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry…
Why was ADVIA Chemistry XPT System recalled?
Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The system may cause samples to remain in an Inprocess state. Test results on a sample that is held Inprocess will not transmit to the LIS. Manual intervention is necessary to complete the processing of the samples that are held Inprocess.
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?
Software Version 1.0.2; Lot Numbers: CA1275000080008, CA1275000090009, CA1275000060006, CA1275000050005, CA1275000070007, CA1275000130013, CA1275000100010, CA1275000120012, CA1275000170017, CA1275000260026, CA1275000270027, CA1275000280028, CA1275000240024, CA1275000200020, CA1275000220022, CA1275000410041
- Product
- ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 16 units: 3 Domestic, 13 Foreign
- Distribution
- Distributed in the states of AZ, CA, and WA, and the countries of Germany, Italy, Spain, and UK.
- Recall date
- April 15, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)