FDA recall Z-2391-2018
Ekla Corporation · Class II · device
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
Distribution
US National Distribution in the states of CA, IL, MN and RI
Key facts
- Status
- Terminated
- Initiation date
- 2016-10-20
- Report date
- 2018-07-18
- Termination date
- 2023-11-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Naperville, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2391-2018