Becton Dickinson & Co.: Medical Device Recall in 2014 - (Recall #: Z-2618-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.

Product Classification:

Class II

Date Initiated: July 23, 2014

Date Posted: September 17, 2014

Recall Number: Z-2618-2014

Event ID: 68991

Reason for Recall:

The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay. One of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results.

Status: Terminated

Product Quantity: 585,048 tests

Code Information:

All Lots with the expiration date January 21, 2014 or later

Distribution Pattern:

US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated