Z-2628-2014Class II

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

Name: Z-2628-2014 BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for...
Creator: Becton Dickinson & Co.
Published: 2014-07-28
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-07-28 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the... on 2014-07-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2628-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-28
Posted: 2014-09-12
Terminated: 2016-01-07
Recalling firm: Becton Dickinson & Co
Product: 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.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
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 root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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, 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.
Product codes and lots: Lot numbers - 4080291 4042217 4048040 4052349 4058242 4073274 4127728

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2628-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2628-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12

Product code JWY

K951539Class IIEnterococcus Screening MediumBecton Dickinson Microbiology Systems / cleared 1995-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)