FDA Medical Device Recalls (openFDA)
Exalenz Bioscience Ltd: 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.
- Recall number
- Z-0042-2012
- Recalling firm
- Exalenz Bioscience Ltd
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-06-07
- Posted
- 2011-10-12
- Terminated
- 2012-07-06
- Reason
- The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted).
- Root cause
- No Marketing Application
- 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.
- Quantity
- 1240 units
- Distribution
- Nationwide Distribution (USA) - including the states of: FL, IL, LA, MA, MS, NY, TN, TX and VA.
- Lot, serial or model codes
- Reorder No. AC00028, Lot numbers: 11-071, 11-0561, 10-00018 and 10-00017.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MSQ
- Firm FEI
- 3005772418
- Firm city
- Modiin
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28