Miami Lakes, FL, United States
Diamedix Corporation recalls
1 recall recorded since 2018, most recently on 5 January 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 5 January 2018
- Terminated
- 5 November 2019
- Reason
- Contains a gel-like contaminant that may affect product performance.
- Distribution
- AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2573-2018, Z-2574-2018
- Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
- Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.