BD Trucount tubes (2016-06-27)

Starting date:

June 27, 2016

Posting date:

July 22, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-59472

• Reason
• Affected products

Affected products

A. BD Trucount tubes

Reason

Pouches contained in the kit lot 6083708 may not be sealed properly. The pouches contained in the kit can be identified with the lot no.16040 and are embossed with "17 02 16 t3" or "16 02 16 T3". Improper storage of Trucount Tubes due to failed pouch closure can affect the performance of the counting beads leading to erroneous results in enumeration assays utilizing Trucount. If the pouch seal is intact and the desiccant included in the pouch is blue, the product may be used. If the pouch seal integrity is compromised and/or the desiccant has turned from blue to lavender, discard the tubes, because exposure to the ambient environment can rapidly degrade the performance of the product.

Affected products