bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

FDA Device Recall #Z-0443-2019 — Class II — October 8, 2018

Recall Summary

Recall Number Z-0443-2019
Classification Class II — Moderate risk
Date Initiated October 8, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm bioMerieux, Inc.
Location Durham, NC
Product Type Devices
Quantity 268

Product Description

bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

Reason for Recall

Some eluates become colored because of remaining hemoglobin in the eluate.

Distribution Pattern

CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh

Lot / Code Information

Lot Z019EA1LB Exp. 28-MAY-2019.

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Z-2671-2025 Class II VITEK¿ 2 Gram-negative AST Test Kits (Cards) co... Jun 26, 2025
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Z-1640-2022 Class II VITEK 2 / MYLA VITEK 2 Software versions 8.0... Jul 13, 2022
Z-1059-2022 Class II VITEK 2 Systems and VITEK 2 with MYLA. Mar 29, 2022
Z-0742-2022 Class II VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. Feb 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.