FDA Device recall Z-0924-2018
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease
- FDA Device
- Class II
- ongoing
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease by Wiener Laboratories, citing internal program testing shows that product may not reach the indicated expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0924-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-11-10 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Wiener Laboratories |
| Distribution | DC, FL, WA |
Product
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
Reason
Internal program testing shows that product may not reach the indicated expiration date.
Identifiers
| code_info | Product Code 1293254, Lot Code 1709228140 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0924-2018%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.