Recall Z-2095-2017 ยท JWY Manual Antimicrobial Susceptibility Test Systems
BioMerieux SA
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
| Date | May 3, 2017 (initiated Apr 25, 2017) |
| Status | Terminated |
| Reason | False susceptible results |
| Root cause | Under Investigation by firm |
| Action | bioMerieux sent an Urgent Product Safety Correction Notice on April 25, 2017 to U. S. consignees. The letter requested that they provide the notice to all appropriate personnel in the laboratory, asking them to identify any possible False Susceptible results. The letter included a Acknowledgment Form to be returned. On this notice the consignee will indicate the number of kits discarded. For customers with questions please contact their local bioMerieux Customer Service representative. |
| Quantity | 3,238 units |
| Distribution | NATIONWIDE DISTRIBUTION TO AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, M, MA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020748 | ETEST ERTAPENEM Ab Biodisk, Apr 29, 2002 |