FDA Device recall Z-1689-2016
Diamedix Is-CMV IgG Test Kit
- FDA Device
- Class II
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class II recall of Diamedix Is-CMV IgG Test Kit by Diamedix, citing product contained an incorrect substrate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1689-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-26 |
| Published | 2016-05-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diamedix |
| Distribution | AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, PR, TN, TX, VA, WI |
Product
Diamedix Is-CMV IgG Test Kit
Reason
Product contained an incorrect substrate.
Identifiers
| code_info | Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016 |
|---|
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-1689-2016%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.