Device product
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Z-2391-2018
Product summary
- Firm
- Ekla Corporation
- Event
- Event 80110
- Status
- Terminated
- Classification
- Class II
- Quantity
- 295 kits
- Official record key
device-enforcement:Z-2391-2018
Official wording
Reason: Incorrect hCG results
Code information: Lot # F606032 (exp 2018-05)
Distribution pattern: US National Distribution in the states of CA, IL, MN and RI
Derived failure modes
-
Unknown
Incorrect hCG results