FDA Recall
Terminated
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Recall: Z-2391-2018
·
Initiated October 20, 2016
Recall
- Recall Number
- Z-2391-2018
- Event Number
- 80110
- Firm
- Ekla Corporation
- FEI Number
- 3008733163
- Product Code
- JHI
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 20, 2016
- Terminated
- November 29, 2023
- Address
- 1707 Quincy Ave, Ste 127, Naperville, IL, 60540-6692
Description
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Reason
Incorrect hCG results
Action
Emails were sent to Distributors and Medical Facilities on 09/21/2016. Follow up phone calls also were made.
Distribution
US National Distribution in the states of CA, IL, MN and RI
Quantity
295 kits