QUANTA FLASH DSDNA CONTROLS (2016-01-25)

Starting date:

January 25, 2016

Posting date:

February 22, 2016

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-57188

• Reason
• Affected products

Affected Products

QUANTA FLASH DSDNA CONTROLS

Reason

The barcode on the quality control certificate that accompanies the product provides the incorrect control name when using the barcode scanner to add a new lot of controls. The barcode on the certificate does not match the control tube labels. The quality control tube labels display the correct description "l" and "h" for the low control and high control respectively while the quality control certificate indicates the incorrect control names, "dsDNAn" for the negative control and "dsDNAp" for the positive control. Users are still able to use the controls but will need to manually enter the correct control name.

Affected products