ADVIA Centaur XPT Immunoassay System
Reported: October 19, 2016 Initiated: April 28, 2016 #Z-0072-2017
Product Description
ADVIA Centaur XPT Immunoassay System
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 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
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur XPT Immunoassay System. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 292 units Total (3 domestically & 289 internationally).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Moderate. Recall number: Z-0072-2017.
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