Recall Z-0934-2019 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
Phoenix AST Indicator, Catalog Number 246004
| Date | Dec 20, 2018 |
| Status | Terminated |
| Reason | Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Product Advisory letters dated 12/20/18 were sent to customers. Amended Urgent Medical Device Product Advisory letters dated 1/23/19 were also sent to customers. |
| Quantity | 62880 total |
| Distribution | The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050745 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML Becton, Dickinson & CO, Apr 29, 2005 |