MICROSCAN LABPRO INFORMATION MANAGER SYSTEM (2015-07-21)

Starting date:

July 21, 2015

Posting date:

August 10, 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-54558

• Reason
• Affected products

Affected Products

A. MICROSCAN LABPRO INFORMATION MANAGER SYSTEM

Reason

Beckman coulter has confirmed the following issues can be encountered when generating organism identifications in the Microscan Labpro information manager system from dried overnight gram negative panels processed on Microscan Autoscan-4 Systems or read manually and entered into the Labpro System.

The use of dried overnight gram negative panels and the Labpro Software System on the Walkaway system is not affected.

Some glucose non-fermenting organisms may display a color change (shade of yellow) in the GLU, SUC, and SOR at 48 hours. When this occurs:

• Labpro software incorrectly allows the operator to manually edit the carbohydrate substrates (specifically GLU, SUC, and SOR) when manually reading dried overnight gram negative (conventional) panels with an ID hold status.
• Labpro software incorrectly overwrites the previously stored carbohydrate substrate results (specifically GLU, SUC, and SOR) when reading dried gram negative overnight (conventional) panels which have an ID hold status on the Autoscan-4 System.
• Labpro software then incorrectly uses the fermenter identification substrates to calculate the biotype which may cause non-fermenters such as an Acinetobacter species to be incorrectly identified as fermenters, for example, a Shigella species.

Affected products