Ekla Corporation: Medical Device Recall in 2018 - (Recall #: Z-2391-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 20, 2016

Date Posted: July 18, 2018

Recall Number: Z-2391-2018

Event ID: 80110

Reason for Recall:

Incorrect hCG results

Status: Terminated

Product Quantity: 295 kits

Code Information:

Lot # F606032 (exp 2018-05)

Distribution Pattern:

US National Distribution in the states of CA, IL, MN and RI

Voluntary or Mandated:

Voluntary: Firm initiated