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U.S. Department of Health and Human Services

Class 2 Device Recall NOVAPLUS(R) Pregnancy Cassette Device with Droppers

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  Class 2 Device Recall NOVAPLUS(R) Pregnancy Cassette Device with Droppers see related information
Date Initiated by Firm October 20, 2016
Create Date July 09, 2018
Recall Status1 Terminated 3 on November 29, 2023
Recall Number Z-2391-2018
Recall Event ID 80110
510(K)Number K112101  
Product Classification Visual, pregnancy hCG, prescription use - Product Code JHI
Product NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS

Product Usage:
pregnancy test
Code Information Lot # F606032 (exp 2018-05)
Recalling Firm/
Manufacturer		 Ekla Corporation
1707 Quincy Ave Ste 127
Naperville IL 60540-6692
For Additional Information Contact
800-328-4215
Manufacturer Reason
for Recall		 Incorrect hCG results
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JHI and Original Applicant = POLYMED THERAPEUTICS, INC
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