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 ROM Plus Rupture of Membrane Test

  • 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 ROM Plus Rupture of Membrane Test see related information
Date Initiated by Firm August 13, 2020
Create Date December 07, 2020
Recall Status1 Open3, Classified
Recall Number Z-0541-2021
Recall Event ID 86255
510(K)Number K110605  
Product Classification Immunoassay for detection of amniotic fluid protein(s). - Product Code NQM
Product Clinical Innovations ROM Plus Collection Kit

IFU:
ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Code Information Model Number: ROM-5025 Lot Number: 192438  Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631
Recalling Firm/
Manufacturer		 Clinical Innovations, LLC
747 W 4170 S
Murray UT 84123-1364
For Additional Information Contact Arpit Sisodiya
801-268-6009
Manufacturer Reason
for Recall		 Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.
FDA Determined
Cause 2		 Process change control
Action On August 17, 2020 through August 19, 2020, the firm sent an "URGENT SAFETY NOTICE" to customers via email informing them that the incorrect swabs (non-scored) were package with their in vitro diagnostic kits and that new instructions and training material will be provided. Customers are instructed to identify any affected products and to complete the response card that is attached to the Customer Notification Letter. Customers are also provided the option of returning the affected products to the Recalling Firm. A company representative will contact and arrange for the return of the product For any questions contact the Recalling Firm at +1-801-268-8200.
Quantity in Commerce 19450 units/kits
Distribution US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NQM and Original Applicant = CLINICAL INNOVATIONS, LLC
-
-