Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The BD MAX MRSA Assay Recalled by Becton Dickinson & Co. Due to The performance of the assay no longer conforms...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Becton Dickinson & Co. directly.
Affected Products
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.
Quantity: 585,048 tests
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 26 states: CA, FL, HI, IL, IN, MD, MI, MN, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI
About Becton Dickinson & Co.
Becton Dickinson & Co. has 183 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report