Recall Z-0474-2016 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Becton Dickinson & Co.
Enterococcus Screen Agar QUAD Plate
| Date | Dec 23, 2015 (initiated Jun 29, 2015) |
| Status | Terminated |
| Reason | The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. |
| Root cause | Under Investigation by firm |
| Action | Becton Dickinson (BD) sent US customers a Urgent Product Recall letter dated June 2015, via UPS. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility. 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. Any product returned to BD will be quarantined and discarded. If further assistance is needed, please contact BD Technical Services at |
| Quantity | 770 |
| Distribution | Worldwide Distribution - US (nationwide) Distribution to the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI and WV., and to the countries of : Canada, Colombia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951539 | ENTEROCOCCUS SCREENING MEDIUM Becton Dickinson Microbiology Systems, Jun 13, 1995 |