Z-2874-2018 Class II Terminated

Recalled by Biomerieux Inc — Hazelwood, MO

FDA device recall Z-2874-2018 was initiated by Biomerieux Inc on Jan 23, 2018 and is designated Class II. Reason for recall: Missing desiccant. The recall status is terminated (terminated Jul 13, 2021). Affected quantity: 57 cartons.

Recall Details

Product Type
Devices
Report Date
Aug 29, 2018
Initiation Date
Jan 23, 2018
Termination Date
Jul 13, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
57 cartons

Product Description

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 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

Code Information

Batch/Lot: 245057043 Exp. Date 19JUN2019

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2874-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.