Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an… — Class II medical device recall Z-1685-2016
Terminated recall by Diamedix Corporation, reported 2016-05-25, distributed nationwide. A gel-like substance was found in kit component, sample diluent , that could potentially compromise product pe
| Recall number | Z-1685-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diamedix Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2014-10-20 |
| Classified | 2016-05-16 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2016-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT |
| Quantity | 697 kits |
| Lot numbers | 20804 |
| Model numbers | 720-540 |
| Expiration dates | 2015-08-31 |
Product
Diamedix Is-Mumps 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.
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-1685-2016. 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.