Date Initiated by Firm |
June 05, 2023 |
Date Posted |
June 28, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2024-2023 |
Recall Event ID |
92451 |
510(K)Number |
K123197
|
Product Classification |
C. Difficile toxin gene amplification assay - Product Code OZN
|
Product |
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 |
Code Information |
UDI/DI , Lot Numbers: 071222022D, 100622022D |
Recalling Firm/ Manufacturer |
Luminex Corporation 4088 Commercial Ave Northbrook IL 60062-1829
|
For Additional Information Contact |
847-400-9000 Ext. 9029
|
Manufacturer Reason for Recall |
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
|
FDA Determined Cause 2 |
Other |
Action |
Luminex issued an Urgent Field Safety Notice - Medical Device Recall notice on 06/05/2023 by email. The notice explained the problem with the stool prep kit, the risk, and requested isolation/quarantine, cease of use, and disposal of the affected products. |
Quantity in Commerce |
114 units |
Distribution |
Worldwide and US Nationwide Distribution |
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 = OZN and Original Applicant = NANOSPHERE, INC
|