FDAFDA · Food and drugs·Recall number Z-1686-2016
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.
Published May 25, 2016 · Recall initiated: October 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Diamedix Corporation
- Distributor
- 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
- Lot # 30804, Catalog # 720-600 Expiration Date April 30, 2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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