FDA Device recall Z-2574-2018
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
- FDA Device
- Class III
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class III recall of Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640 by Diamedix, citing contains a gel-like contaminant that may affect product performance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2574-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-01-05 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diamedix |
| Distribution | AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, WI |
Product
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Reason
Contains a gel-like contaminant that may affect product performance.
Identifiers
| code_info | Lot T0006 Exp. 05/31/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2574-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.