ADVIA CENTAUR XPT ( 2015-07-31)

Starting date:

July 31, 2015

Posting date:

August 18, 2015

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-54702

• Reason
• Affected products

Affected Products

A. ADVIA CENTAUR XPT

Reason

1. The "reset ranges" button in the ranges window of a TDEF currently does not properly reset predefined over dilution points. This impacts the assay THCG which has a predefined over dilution point. If the "reset ranges" button is pressed for THCG, the assay will lose its predefined over dilution point and diluted results which are below the over dilution point will not be flagged as over diluted.
2. If the system is set up to process samples with the settings for rack id, positions mode and rack order mode activated at the same time, the system will not process test orders, if there are no sample identifiers (SIDS) defined for the tubes. In addition, when processing samples with these settings and a second rack is received for processing within 15-30 seconds of the ejection of the 1st rack, the system may incorrectly use the orders of the 1st rack when processing the 2nd rack. This will cause transposition of patient results.
3. The maintenance operation to automatically move completed test data to historical does not move SIDS associated with multiple assays to the historical database. For example, if SID "XYZ" had been run for tests AFP and TSH, that SID would not be moved to the historical database by the "move to historical" maintenance activity.
4. The visual status light currently does not light up for certain scenarios. The visual status light will not light up for unacknowledged warnings or errors associated with the following tabs: samples, reagents, calibrations, and supplies.
5. The system may incorrectly use a primary reagent pack with a lower priority when a primary reagent pack with a higher priority is available. This may also result in the instrument using an uncalibrated primary pack if the assay has the "Assign Cal" parameter enabled within the TDEF. Since the reagent pack was un-calibrated, the system will not generate results and will only report a relative light unit (RLU) value.
6. In the QC definition screen, the system has a field for "+/- range". The system considers this parameter to be the 2 standard deviation (SD) range value. The QC definition fields are all handled by the system under the assumption that the values being entered are for a +/- 2sd range. if users are unaware of this, they could enter in values associated with either a wider or smaller range and the instrument would be unaware. This can cause qc flagging to be incorrect.
7. When the system is configured to a date/time format other than English (United States), the date/time information for calibration events is not displayed in the quality control windows.

Affected products