BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to

FDA device recall Z-2628-2014 · posted 2014-09-12 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

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

Action taken

BD 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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JWY

Quantity affected

28540

Distribution

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,

Date initiated

2014-07-28

Date posted

2014-09-12

Date terminated

2016-01-07

Location

Sparks, MD

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