FDAClass IIJuly 18, 2018

NOVAPLUS(R) Pregnancy Cassette Device with Droppers recall

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

Why was NOVAPLUS(R) Pregnancy Cassette Device with Droppers recalled?

Incorrect hCG results

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # F606032 (exp 2018-05)

Product
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Recalling firm
Ekla Corporation
Quantity
295 kits
Distribution
US National Distribution in the states of CA, IL, MN and RI
Recall date
July 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls