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 Testsee related information
Date Initiated by FirmAugust 13, 2020
Create DateDecember 07, 2020
Recall Status1 Terminated 3 on May 24, 2024
Recall NumberZ-0541-2021
Recall Event ID 86255
510(K)NumberK110605 
Product Classification Immunoassay for detection of amniotic fluid protein(s). - Product Code NQM
ProductClinical 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
FEI Number 1000220650
Recalling Firm/
Manufacturer		 Clinical Innovations, LLC
747 W 4170 S
Murray UT 84123-1364
For Additional Information ContactArpit 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
ActionOn 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 Commerce19450 units/kits
DistributionUS: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
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 = NQM
-
-