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Recall Observatory FDA recall evidence

Device 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.

Z-1686-2016

October 20, 2014

Class II

Product summary

Firm
Diamedix Corporation
Event
Event 73694
Status
Terminated
Classification
Class II
Quantity
588 kits
Official record key
device-enforcement:Z-1686-2016

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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