BD MAX System (2018-10-03)

Starting date:

October 3, 2018

Posting date:

October 26, 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-68092

• Reason
• Affected products

Affected products

BD MAX System

Reason

BD has confirmed based on customer complaint investigations that a limited number of BD max systems were manufactured with optical filters that have shown a potential to produce a false positive result for Candida glabrata when processing samples positive for Trichomonas vaginalis during testing with the BD max vaginal panel. To prevent any future occurrence BD will be replacing all impacted readers.

Affected products