Advia Chemistry XPT Instrument (2021-05-25)
- Starting date:
- May 25, 2021
- Posting date:
- June 17, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75809
Last updated:
2021-06-17
Affected Products
Advia Chemistry XPT Instrument
Reason
Siemens is advising customers of an issue with the ADVIA Chemistry XPT system and providing instructions on actions that laboratories must take. Siemens Healthcare Diagnostics Inc. has confirmed that the system behavior in all commercially available software versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) for the ADVIA Chemistry XPT system may not be aligned with customer expectations for the current default mixer failure detection setting of "2: Warning+STOP" (option 2 in System Parameters) for the Reagent 1 and Reagent 2 mixer assemblies.Customers who have chosen to use the mix verification setting of 0: ignore, 1: warning or 3: warning+wait are not impacted by this issue.
Affected products
Advia Chemistry XPT Instrument
Lot or serial number
CA1275003840384
CA1275004220422
CA1275004250425
CA1275006080608
CA1275006090609
Model or catalog number
10723034
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES