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U.S. Department of Health and Human Services

Class 2 Device Recall BD MAX MRSA Assay

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  Class 2 Device Recall BD MAX MRSA Assay see related information
Date Initiated by Firm July 23, 2014
Date Posted September 10, 2014
Recall Status1 Terminated 3 on May 09, 2016
Recall Number Z-2618-2014
Recall Event ID 68991
510(K)Number K120138  
Product Classification System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct sp - Product Code NQX
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.
Code Information All Lots with the expiration date January 21, 2014 or later
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact
410-316-4000
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NQX and Original Applicant = BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
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