FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: 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.
- Recall number
- Z-2618-2014
- Recalling firm
- Becton Dickinson & Co.
- 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.
- Status
- Terminated
- Initiated
- 2014-07-23
- Posted
- 2014-09-10
- Terminated
- 2016-05-09
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Becton Dickinson sent an Field Correction Notification initiated on July 23, 2014. US customers were contacted via letters sent by UPS. The letter identified the product the problem and the action needed to be taken by the customer. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter. Any product returned to BD will be quarantined and discarded. Nonetheless, you may observe some false positive results for MSSA strains when using the above referenced product. Please contact the BD Technical Service Department at 1-800-638-8663 if you have observed an increase in MSSA false positive results or have failed the above referenced CAP surveys.
- Quantity
- 585,048 tests
- Distribution
- 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.
- Lot, serial or model codes
- All Lots with the expiration date January 21, 2014 or later
- 510(k) numbers
- ["K120138"]
- PMA numbers
- not on file
- Product code
- NQX
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28