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

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  Reason
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  Affected products

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