Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualita...

FDA Device Recall #Z-2736-2014 — Class II — June 17, 2013

Recall Summary

Recall Number Z-2736-2014
Classification Class II — Moderate risk
Date Initiated June 17, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nanosphere, Inc.
Location Northbrook, IL
Product Type Devices
Quantity 20 extraction trays

Product Description

Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.

Reason for Recall

There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.

Distribution Pattern

Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.

Lot / Code Information

Part Number: 20-009-021; Lot Numbers: 052113021C

Other Recalls from Nanosphere, Inc.

Recall # Classification Product Date
Z-2236-2014 Class II Verigene BC-GN Test Kit (Catalog number 20-005-... Jul 9, 2014
Z-2170-2014 Class II Verigene Gram-Negative Blood Culture Nucleic Ac... Apr 17, 2014
Z-2559-2014 Class III Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Tes... Mar 18, 2014
Z-2168-2014 Class III Nanosphere Verigene Each CDF test consists ... Oct 16, 2013
Z-2685-2014 Class II The Verigene Enteric Pathogens Nucleic Acid Tes... Oct 10, 2013

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.