Enterococcus Screen Agar QUAD Plate
This recall has been terminated (originally issued December 23, 2015).
- Recall Initiated
- June 29, 2015
- Posted
- December 23, 2015
- Terminated
- August 12, 2016
- Recall Number
- Z-0474-2016
- Quantity
- 770
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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, India, Mexico and Europe.
Lot / Code Info
catalog number 222201. Lot numbers 5064938, 5085954, 5105509, and 5133580
Root Cause
Under Investigation by firm
Action Taken
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 1-800-638-8663.