BD Max MRSA Assay (2014-07-18)

Starting date:

July 18, 2014

Posting date:

August 1, 2014

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-40815

• Reason
• Affected products

BD Max MRSA Assay

Reason

Based on investigation of incorrect results related to the College of American Pathologists (CAP) surveys MRS5-A 2014 and MRS5-B 2014 using the BD-Max MRSA Assay it was confirmed that one of the samples for each of the surveys yielded some false positive results. While there is the potential for false positive result for specimens from patients who are positive for certain strains of Methicillin-Sensitive Staphylococcus aureus (MSSA) when present at high loads, BD believes that such an occurence is unlikely and overall clinical performance would not be affected.

Affected products