FDA Device recall Z-1342-2014
H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
- FDA Device
- Class II
- terminated
- Published 2014-04-16
On 2014-04-16 the FDA classified a Class II recall of H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054 by Lumiquick Diagnostics, citing products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1342-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-04 |
| Published | 2014-04-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lumiquick Diagnostics |
| Distribution | CA, FL, NJ, NY, TX |
Product
H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
Reason
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Identifiers
| code_info | Catalog number: 71024, All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1342-2014%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.