H — Class II medical device recall Z-1342-2014
Terminated recall by LumiQuick Diagnostics Inc., reported 2014-04-16, distributed in CA, FL, NJ, NY, TX. Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
| Recall number | Z-1342-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LumiQuick Diagnostics Inc., Santa Clara, CA, United States |
| Recall initiated | 2014-03-04 |
| Classified | 2014-04-07 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2014-05-09 |
| Distributed | CA, FL, NJ, NY, TX |
| Model numbers | 71024 |
Product
H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
Reason for recall
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
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-1342-2014. 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.