Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended...

FDA Device Recall #Z-1687-2016 — Class II — October 20, 2014

Recall Summary

Recall Number Z-1687-2016
Classification Class II — Moderate risk
Date Initiated October 20, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Diamedix Corporation
Location Miami Lakes, FL
Product Type Devices
Quantity 94 kits

Product Description

Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.

Reason for Recall

A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

Distribution Pattern

Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.

Lot / Code Information

Lot # 51104, Catalog # 720-640 Expiration Date August 31, 2015

Other Recalls from Diamedix Corporation

Recall # Classification Product Date
Z-2573-2018 Class III Diamedix Is-Mumps IgG Enzyme Immunoassay Test K... Jan 5, 2018
Z-2574-2018 Class III Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Tes... Jan 5, 2018
Z-1689-2016 Class II Diamedix Is-CMV IgG Test Kit Mar 26, 2015
Z-1686-2016 Class II Diamedix Is-EBV-VCA IgG Test Kit Diamedix I... Oct 20, 2014
Z-1685-2016 Class II Diamedix Is-Mumps IgG Test Kit Diamedix Is-... Oct 20, 2014

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.