Medical device recalls Moderate risk

Ekla Corporation recalls NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pr…

Recall date
October 20, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2391-2018
FDA classification
Class II
Brand / firm
Ekla Corporation
Sold / distributed
US National Distribution in the states of CA, IL, MN and RI

Why it was recalled

Incorrect hCG results

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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