BD MAX TNA MMK (SPC) (2018-05-04)

Starting date:

May 4, 2018

Posting date:

June 22, 2018

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-67066

• Reason
• Affected products

Affected products

BD MAX TNA MMK (SPC)

Reason

Through internal testing BD has determined that an enzyme used in the production of the dried PCR Master Mix reagent included in specific lots is not meeting performance expectations throughout its shelf life. Data indicate that enzyme residual activity may appear above expected levels.

Affected products