bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instrum...

FDA Device Recall #Z-2874-2018 — Class II — January 23, 2018

Recall Summary

Recall Number Z-2874-2018
Classification Class II — Moderate risk
Date Initiated January 23, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Biomerieux Inc
Location Hazelwood, MO
Product Type Devices
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

Lot / Code Information

Batch/Lot: 245057043 Exp. Date 19JUN2019

Other Recalls from Biomerieux Inc

Recall # Classification Product Date
Z-1236-2026 Class II VITEK 2 Gram-negative Susceptibility Cards Cont... Jan 5, 2026
Z-1464-2024 Class I VITEK 2 - AST Test kits (in vitro diagnostic te... Mar 14, 2024
Z-1201-2023 Class II MYLA comprises AST Filters in conjunction with ... Feb 6, 2023
Z-0798-2023 Class II VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700 Nov 9, 2022
Z-0786-2023 Class II API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 Nov 9, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.