NOVAPLUS — Class II medical device recall Z-2391-2018
Terminated recall by Ekla Corporation, reported 2018-07-18, distributed in CA, IL, MN, RI. Incorrect hCG results
| Recall number | Z-2391-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ekla Corporation, Naperville, IL, United States |
| Recall initiated | 2016-10-20 |
| Classified | 2018-07-09 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2023-11-29 |
| Distributed | CA, IL, MN, RI |
| Quantity | 295 kits |
| Lot numbers | F606032 |
| Model numbers | VPT1-CASS |
Product
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Reason for recall
Incorrect hCG results
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-2391-2018. 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.