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U.S. Department of Health and Human Services

Class 2 Device Recall IDkit:HP" Two Test System

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 Class 2 Device Recall IDkit:HP" Two Test Systemsee related information
Date Initiated by FirmJune 07, 2011
Date PostedOctober 12, 2011
Recall Status1 Terminated 3 on July 06, 2012
Recall NumberZ-0042-2012
Recall Event ID 59891
Product Classification Test, urea (breath or blood) - Product Code MSQ
ProductIDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.
Code Information Reorder No. AC00028, Lot numbers: 11-071, 11-0561, 10-00018 and 10-00017.
FEI Number 3005772418
Recalling Firm/
Manufacturer		 Exalenz Bioscience Ltd
Hamaayan 4
Modiin Israel
For Additional Information ContactMark Hood
704-707-6162
Manufacturer Reason
for Recall		The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted).
FDA Determined
Cause 2		No Marketing Application
ActionThe firm, Exalenz Bioscience Ltd. notified consignees located in the United States of the recall by telephone, electronic mail, or written correspondence between June 9, 2011 and June 30, 2011. The letter informed consignees that Exalenz will immediately cease marketing the IDkit:HP TWO test in the United States. Consignees were instructed to return shipment of the IDkit:HP TWO test kits that they have in their possession to the companys US warehouse. For question call the VP of North American Sales at 704-770-6162 or VP of Marketing at 617-794-6936.
Quantity in Commerce1240 units
DistributionNationwide Distribution (USA) - including the states of: FL, IL, LA, MA, MS, NY, TN, TX and VA.
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.
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