Class II — Ekla Corporation
| Recalling firm | EKLA Corporation |
|---|---|
| Registered facility | EKLA CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect hCG results |
| Product | NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test |
| Quantity | 295 kits |
| Distribution | US National Distribution in the states of CA, IL, MN and RI |
| Initiated | 2016-10-20 |
| Classified | 2018-07-09 |
| Terminated | 2023-11-29 |
| Recall number | Z-2391-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ekla Corporation (Z-2391-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80110/
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