Recall Z-2874-2018 ยท JST Kit, Fastidious Organisms
Biomerieux Inc
bioMrieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
| Date | Jan 23, 2018 |
| Status | Terminated |
| Reason | Missing desiccant. |
| Root cause | Nonconforming Material/Component |
| Action | bioMrieux sent to customers letter requesting the following actions; - Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. - Please dispose of any VITEK 2 NH ID test kits, Lot 2450570403, in your stock that were received prior to 25-JAN-2018 and do not have a blue sticker on the carton. Please contact your local bioMrieux representative for replacement of destroyed test kits. - Please store this letter with your bioMrieux VITEK 2 System documentation. - Complete the attached Acknowledgement Form and return it to your local bioMri |
| Quantity | 57 cartons |
| Distribution | US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT. VA. VT. WA. WI, and WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.