Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a coun...

FDA Device Recall #Z-1478-2013 — Class III — January 23, 2013

Recall Summary

Recall Number Z-1478-2013
Classification Class III — Low risk
Date Initiated January 23, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bion Enterprises Ltd
Location Des Plaines, IL
Product Type Devices
Quantity 201 units

Product Description

Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

Reason for Recall

Affected products have a labeled expiration date of one year too long.

Distribution Pattern

Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)

Lot / Code Information

Product Code: CCM-9914; Lot: CCM-0281

Other Recalls from Bion Enterprises Ltd

Recall # Classification Product Date
Z-1479-2013 Class III Plastic bottle containing 3.5 mL of IgG FITC Co... Jan 23, 2013
Z-1477-2013 Class III Plastic bottle containing 10.5 mL of IgG Conjug... Jan 23, 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.