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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL Vancomycin Screen Agar

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 Class 2 Device Recall BD BBL Vancomycin Screen Agarsee related information
Date Initiated by FirmJuly 28, 2014
Date PostedSeptember 12, 2014
Recall Status1 Terminated 3 on January 07, 2016
Recall NumberZ-2628-2014
Recall Event ID 69062
510(K)NumberK951539 
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
ProductBD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
Code Information Lot numbers -  4080291 4042217 4048040 4052349 4058242 4073274 4127728 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
BD Diagnostic Systems
Sparks MD 21152-9212
For Additional Information ContactMs. Gail Claiborne
410-316-4000
Manufacturer Reason
for Recall		These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Agar that allows susceptible enterococci to grow appears as a falsely resistant culture. If a lab does not QC, the error would be identified as falsely resistant enterococci would have further AST workup. There could be a delay in the identification of false-resistance
FDA Determined
Cause 2		Under Investigation by firm
ActionBD Diagnostic System sent an Urgent Product Recall letter dated July 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate you may have been shipped the above-referenced lot numbers of product between March 5, 2014 and June 5, 2014. Please discontinue use of these lot numbers and discard any remaining packages. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663. 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. BD has asked distributors to send their customer list to BD for follow up.
Quantity in Commerce28540
DistributionWorldwide Distribution: US (Nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to the countries of Belgium, Canada, Colombia, India, Mexico, Singapore and Taiwan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWY
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