Recall Z-1686-2016— Diamedix Corporation
Class II · Terminated
Class II FDA medical device recall by Diamedix Corporation, initiated 2014-10-20, terminated 2016-12-14. It names one FDA 510(k) clearance: K981812. 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.. Reason: A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance..
- Recalling firm
- Diamedix Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-20
- Terminated
- 2016-12-14
- Firm location
- Miami Lakes, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.