FDA Device recall Z-2391-2018
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat by Ekla, citing incorrect hCG results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2391-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-20 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ekla |
| Distribution | CA, IL, MN, RI |
Product
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Reason
Incorrect hCG results
Identifiers
| code_info | Lot # F606032 (exp 2018-05) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2391-2018%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.