ADVIA Centaur XPT Instrument (2020-02-26)

Starting date:

February 26, 2020

Posting date:

March 13, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72575

Last updated: 2020-03-13

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  Reason
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  Affected products

Affected Products

ADVIA Centaur XPT Instrument

Reason

Siemens Healthcare Diagnostics has identified two software (SW) issues in ADVIA Centaur XPT Software Versions 1.5.1 and below. These issues are as follows:

1. ADVIA Centaur XPT SW version 1.4 and below—The system reaches the maximum number ofcalibrator definitions allowed by the software, and the operator is unable to scan newcalibration definitions or delete old/expired definitions. A similar condition could occur whenscanning a new assay calibrator card where the lot number information already exists in thedatabase.
2. ADVIA Centaur XPT SW version 1.5 and 1.5.1—The system can sporadically produce an errorcondition during the Automatic or Manual Daily Cleaning Procedure (DCP). Below are the threeerror conditions that can be observed with this issue:
   • 01 302 01 017—A sensor is not detected in allowed range during the move ofluminometer rotor.
   • 01 600 10 01—Luminometer is offline.
   • 01 302 02 05—Motor busy error during the move of the waste probe.

The issues described above will be corrected in a future release of ADVIA Centaur XPT software.

Affected products