Health product recall

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

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

BD MAX System

Lot or serial number
  • CT0280
  • CT0304
  • CT0499
  • CT0615
  • CT0754
  • CT1288
Model or catalog number
  • 441916
Companies
Manufacturer

Becton Dickinson and Company

7 Loveton Circle

Sparks

21152

UNITED STATES