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U.S. Department of Health and Human Services

Class 2 Device Recall Detector H. Pylori

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  Class 2 Device Recall Detector H. Pylori see related information
Date Initiated by Firm August 25, 2023
Date Posted January 10, 2024
Recall Status1 Open3, Classified
Recall Number Z-0702-2024
Recall Event ID 93646
510(K)Number K980798  
Product Classification Helicobacter pylori - Product Code LYR
Product Detector H. Pylori, Catalog Number IHP-30
Code Information UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31
Recalling Firm/
Manufacturer		 Immunostics, Inc.
38 Industrial Way E Ste 1
Eatontown NJ 07724-3334
For Additional Information Contact Young Mi Kim
651-815-9805
Manufacturer Reason
for Recall		 Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action On August 25, 2023, the firm initiated the recall with its distributor, who in turn notified affected customers on September 6, 2023. Customers were instructed to dispose of the product and submit a response form directly to Immunostics, the recalling firm. Customers may contact Immunostics by calling toll free at 1800-722-7505, Monday through Thursday, 8:00 AM to 4:30 PM, Eastern Time and Friday 8:00 AM to 4:00 PM Eastern Time or via email at technical@immunostics.com
Quantity in Commerce 10 kits
Distribution Product distributed to CA and MO.
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 = LYR and Original Applicant = PRINCETON BIOMEDITECH CORP.
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