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Z-2628-2014 Class II Terminated

Recalled by Becton Dickinson & Co. — Sparks, MD

FDA device recall Z-2628-2014 was initiated by Becton Dickinson & Co. on Jul 28, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jan 7, 2016). Affected quantity: 28540.

Recall Details

Product Type: Devices
Report Date: Sep 24, 2014
Initiation Date: Jul 28, 2014
Termination Date: Jan 7, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28540

Product 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.

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

Distribution Pattern

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.

Code Information

Lot numbers - 4080291 4042217 4048040 4052349 4058242 4073274 4127728

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2628-2014
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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