Recall Z-0234-2015 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Biomerieux
Etest Ceftaroline (CPT32) US B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
| Date | Nov 19, 2014 (initiated Oct 16, 2014) |
| Status | Terminated |
| Reason | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. |
| Root cause | Labeling Change Control |
| Action | Consignees of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on October 16th, 2014. Additionally, the bioMrieux United States subsidiary notified US consignees of the FSCA notification via FedEx on October 23rd, 2014. |
| Quantity | 652 devices |
| Distribution | Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121002 | ETEST CEFTAROLINE bioMerieux, Inc., Oct 12, 2012 |