Z-0042-2012

IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St...

Name: Z-0042-2012 IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St...
Creator: Exalenz Bioscience Ltd
Published: 2011-06-07
License: https://open.fda.gov/license/

Meridian Bioscience Israel Ltd. / initiated 2011-06-07 / Terminated

FDA source

Exalenz Bioscience Ltd began a recall of IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz... on 2011-06-07. The reason FDA records is "The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0042-2012
Status: Terminated
Initiated: 2011-06-07
Posted: 2011-10-12
Terminated: 2012-07-06
Recalling firm: Meridian Bioscience Israel 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.
Product code: MSQ Test, Urea (Breath Or Blood)
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 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 in commerce: 1240 units
Distribution: Nationwide Distribution (USA) - including the states of: FL, IL, LA, MA, MS, NY, TN, TX and VA.
Product codes and lots: Reorder No. AC00028, Lot numbers: 11-071, 11-0561, 10-00018 and 10-00017.

Product code MSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)