Z-2391-2018Class II

NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS

Name: Z-2391-2018 NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS
Creator: Ekla Corporation
Published: 2016-10-20
License: https://open.fda.gov/license/

Ekla Corporation / initiated 2016-10-20 / Terminated / root cause: manufacturing process

FDA source

Ekla Corporation began a recall of NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test on 2016-10-20. FDA classified it as Class II and gives the reason as "Incorrect hCG results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2391-2018
Classification: Class II
Status: Terminated
Initiated: 2016-10-20
Posted: 2018-07-09
Terminated: 2023-11-29
Recalling firm: Ekla Corporation
Product: NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: Incorrect hCG results
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Emails were sent to Distributors and Medical Facilities on 09/21/2016. Follow up phone calls also were made.
Quantity in commerce: 295 kits
Distribution: US National Distribution in the states of CA, IL, MN and RI
Product codes and lots: Lot # F606032 (exp 2018-05)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2391-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2391-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-09

Product code JHI

K112101Class IIFastep Hcg Pregancy Serum/urine Cassette and Dipstick TestsPolymed Therapeutics, Inc. / cleared 2012-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)