Diamedix Is-CMV IgG Test Kit — Class II medical device recall Z-1689-2016
Terminated recall by Diamedix Corporation, reported 2016-05-25, distributed in AZ, CA, FL, GA, KY, MA, MI, MN…. Product contained an incorrect substrate.
| Recall number | Z-1689-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diamedix Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2015-03-26 |
| Classified | 2016-05-17 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2018-11-14 |
| Distributed | AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, PR, TN, TX, VA, WI |
| Quantity | 150 kits |
| Lot numbers | 10105 |
| Model numbers | 720-320 |
| Expiration dates | 2016-01-31 |
Product
Diamedix Is-CMV IgG Test Kit
Reason for recall
Product contained an incorrect substrate.
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-1689-2016. 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.