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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: May 16, 2016
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Affected Products

Product: Diamedix Is-Mumps 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.

Lot # 20804, Catalog # 720-540. Expiration Date August 31, 2015

Lot Numbers:
20804
Product: Diamedix Is-EBV-VCA 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.

Lot # 30804, Catalog # 720-600 Expiration Date April 30, 2015

Lot Numbers:
30804
Product: 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.

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

Lot Numbers:
51104

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73694
Status: Resolved
Manufacturer: Diamedix Corporation
Manufactured In: United States
Units Affected: 3 products (697 kits; 588 kits; 94 kits)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.