FDA Medical Device Recalls (openFDA)
Ekla Corporation: NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
- Recall number
- Z-2391-2018
- Recalling firm
- Ekla Corporation
- Product
- NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
- Status
- Terminated
- Initiated
- 2016-10-20
- Posted
- not on file
- Terminated
- 2023-11-29
- Reason
- Incorrect hCG results
- Root cause
- Process control
- Action
- Emails were sent to Distributors and Medical Facilities on 09/21/2016. Follow up phone calls also were made.
- Quantity
- 295 kits
- Distribution
- US National Distribution in the states of CA, IL, MN and RI
- Lot, serial or model codes
- Lot # F606032 (exp 2018-05)
- 510(k) numbers
- ["K112101"]
- PMA numbers
- not on file
- Product code
- JHI
- Firm FEI
- 3008733163
- Firm city
- Naperville
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28