Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro… — Class III medical device recall Z-2574-2018
Terminated recall by Diamedix Corporation, reported 2018-08-08, distributed in AZ, CA, FL, IL, IN, KY, MA, MI…. Contains a gel-like contaminant that may affect product performance.
| Recall number | Z-2574-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diamedix Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2018-01-05 |
| Classified | 2018-07-28 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2019-11-05 |
| Distributed | AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, WI |
| Quantity | 147 |
| Lot numbers | T0006 |
| Model numbers | 720-640 |
| Expiration dates | 2018-05-31 |
Product
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Reason for recall
Contains a gel-like contaminant that may affect product performance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2574-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.