IDkit: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.
FDA Recall Z-0042-2012 · Posted 2011-10-12
Recalling FirmExalenz Bioscience Ltd
Recall StatusTerminated
Product CodeMSQ
Date Initiated2011-06-07
Date Terminated2012-07-06
Product Quantity1240 units
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).
Firm Action
The 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.
Root Cause
No Marketing Application
Distribution Pattern
Nationwide Distribution (USA) - including the states of: FL, IL, LA, MA, MS, NY, TN, TX and VA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.