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Recall Observatory FDA recall evidence

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.

Z-2874-2018

January 23, 2018

Class II

Product summary

Firm
Biomerieux Inc
Event
Event 80491
Status
Terminated
Classification
Class II
Quantity
57 cartons
Official record key
device-enforcement:Z-2874-2018

Official wording

Reason: Missing desiccant.

Code information: Batch/Lot: 245057043 Exp. Date 19JUN2019

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Missing desiccant.