Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall NOVAPLUS(R) Pregnancy Cassette Device with Dropperssee related information
Date Initiated by FirmOctober 20, 2016
Create DateJuly 09, 2018
Recall Status1 Terminated 3 on November 29, 2023
Recall NumberZ-2391-2018
Recall Event ID 80110
510(K)NumberK112101 
Product Classification Visual, pregnancy hCG, prescription use - Product Code JHI
ProductNOVAPLUS(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)
FEI Number 3008733163
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
ActionEmails were sent to Distributors and Medical Facilities on 09/21/2016. Follow up phone calls also were made.
Quantity in Commerce295 kits
DistributionUS National Distribution in the states of CA, IL, MN and RI
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JHI
-
-