BD MAX MRSA Assay Recalled for False Positive Results
Becton Dickinson is recalling 585,048 BD MAX MRSA Assay tests because some samples yielded false positive results during CAP surveys.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard involves false positive results in a diagnostic test, which is a performance issue rather than a direct physical injury or high-risk pathogen exposure.
Plain-English summary
Becton Dickinson & Co. is recalling 585,048 units of the BD MAX MRSA Assay, catalogue #442953. This is an automated qualitative in vitro diagnostic test used to detect Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs. The recall covers all lots with an expiration date of January 21, 2014, or later.
The recall was initiated because the performance of the assay no longer conforms to the statement in the Analytical Specificity section of the Package Insert. Specifically, one of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results. The source text notes that 111 out of 111 MSSA strains tested at extremely high concentrations produced negative results.
The affected products were distributed in the US, 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. Healthcare facilities and laboratories should stop using the affected tests and contact Becton Dickinson for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 585,048
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots with the expiration date January 21
- 2014 or later
Distribution
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