ATELLICA CH 930 Analyzer (2020-02-28)

Starting date:

February 28, 2020

Posting date:

March 13, 2020

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-72593

Last updated: 2020-03-13

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  Reason
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  Affected products

Affected Products

ATELLICA CH 930 Analyzer

Reason

On the ATELLICA CH 930 Analyzer, after editing test definition (TDEF) parameters for an assay, if the changes are not 'saved' using the steps in the online help, and the user abruptly selects another assay to edit, there is a potential to overwrite some parameters of the original assay that was being edited with the settings of the newly selected assay if the 'save' button on the displayed dialog box is clicked. If the  ATELLICA CH 930 Analyzer runs out of reagent in one well of a reagent pack while processing an auto-rerun or auto dilution, the system attempts to use the next well of a reagent pack, however, if the next well of the pack is not calibrated or is expired, the auto-rerun or autodilution will be reported as zero (0) instead of 'error'.

Affected products