Recall Z-0439-2016 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Biomerieux
Etest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
| Date | Dec 23, 2015 (initiated Nov 19, 2015) |
| Status | Terminated |
| Reason | Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. |
| Root cause | Process change control |
| Action | Consignees (Subsidiaries and Distributors) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on November 24th, 2015. Additionally, the bioMrieux United States subsidiary notified US consignees (distributors/end-users) of the FSCA notification via FedEx on December 2nd, 2015. |
| Quantity | 5458 units |
| Distribution | Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953223 | PIPERACILIN TAZOBACTAM 4 UG Ab Biodisk, Aug 15, 1995 |