Recall Z-1226-2017 ยท JWY Manual Antimicrobial Susceptibility Test Systems
BioMerieux SA
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria
| Date | Jan 18, 2017 |
| Status | Terminated |
| Reason | Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods. |
| Root cause | Under Investigation by firm |
| Action | BioMerieux sent an Urgent Field Safety Notice electronically on 1/18/2017. The notice included instructions and recommendations for users of the product. The notice included an acknowledgment form to be returned. Customers with questions were instructed to contact their BioMerieux representative. For questions regarding this recall call 919-620-3396. |
| Quantity | 7,160 units |
| Distribution | Worldwide Distribution - US including AZ, AR, CA, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WI, and Internationally to Algeria, United Arab Emirates, Austria, Australia, Brazil, Cambodia, Canada, Chile, Chine, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990722 | ETEST FOR CEFUROXIME Ab Biodisk, Apr 22, 1999 |