Naperville, IL, United States
Ekla Corporation recalls
1 recall recorded since 2018, most recently on 20 October 2016. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 October 2016
- Terminated
- 29 November 2023
- Reason
- Incorrect hCG results
- Distribution
- US National Distribution in the states of CA, IL, MN and RI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2391-2018
- NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.