FDA Device

NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test

Hazard

Incorrect hCG results

What You Should Do

Remedy

Emails were sent to Distributors and Medical Facilities on 09/21/2016. Follow up phone calls also were made.

Products

NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Brand
Ekla Corporation
UPC
Lot # F606032 (exp 2018-05)

Units Affected

295 kits