FDA Device recall Z-1685-2016
Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detect…
- FDA Device
- Class II
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class II recall of Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detect… by Diamedix, citing A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1685-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-20 |
| Published | 2016-05-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diamedix |
| Distribution | US |
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
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Identifiers
| code_info | Lot # 20804, Catalog # 720-540. Expiration Date August 31, 2015 |
|---|
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-1685-2016%22
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