FDA-Device2018-07-18Class II
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Ekla Corporation
Hazard
Incorrect hCG results
Sold states
US National Distribution in the states of CA, IL, MN and RI
Affected count
295 kits
Manufactured in
1707 Quincy Ave Ste 127, Naperville, IL, United States
Products
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2391-2018Don't want to check this manually?
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