ADVIA Centaur XPT Immunoassay System recall
ADVIA Centaur XPT Immunoassay System
Why was ADVIA Centaur XPT Immunoassay System recalled?
The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.
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?
None
- Product
- ADVIA Centaur XPT Immunoassay System
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 292 units Total (3 domestically & 289 internationally)
- Distribution
- Worldwide Distribution - US including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN
- Recall date
- October 19, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)