Device 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.
Z-1687-2016
Product summary
- Event
- Event 73694
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94 kits
- Official record key
device-enforcement:Z-1687-2016
Official wording
Reason: A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Code information: Lot # 51104, Catalog # 720-640 Expiration Date August 31, 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
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.