BD 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.
Enforcement
- Recall Number
- Z-2628-2014
- Event ID
- 69062
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 24, 2014
- Initiation Date
- July 28, 2014
- Classification Date
- September 12, 2014
- Termination Date
- January 7, 2016
- Address
- 7 Loveton Cir, BD Diagnostic Systems, Sparks, MD, 21152-9212, United States
Description
BD 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.
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
Lot numbers - 4080291 4042217 4048040 4052349 4058242 4073274 4127728
Worldwide 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.
28540