Softwares for VITEK Systems (2015-02-17)

Starting date:

February 17, 2015

Posting date:

May 21, 2015

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-53389

• Reason
• Affected products

Recalled Products

1. Software for VITEK 2 Compact 30 System
2. Software for VITEK 2 Compact 60 System
3. Software for VITEK 2 System- VITEK 2

Reason

VITEK 2 7.01 software introduced a feature (enable - convention for highest reportable MIC) that can be used to modify the reporting convention when an AST result is within the highest reportable mic range.  Advanced expert system (AES) parameter sets are configurable in the VITEK 2 software to allow users to select mic breakpoint interpretation as well as AES functionality related to recommended guidelines. When "enabled - convention for highest reportable MIC configuration option modifies the highest reportable MIC value for each specific antimicrobial to half its doubling dilution and displays the value with a "greater than" symbol.

Affected products