FDA recall Z-2874-2018

Biomerieux Inc · Class II · device

Product

bioM¿rieux 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.

Reason for recall

Missing desiccant.

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

Key facts

Status
Terminated
Initiation date
2018-01-23
Report date
2018-08-29
Termination date
2021-07-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2874-2018