Z-0003-2008

BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek...

Name: Z-0003-2008 BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek...
Creator: Meretek Diagnostics, Inc.
Published: 2007-05-02
License: https://open.fda.gov/license/

Meretek Diagnostics, Inc. / initiated 2007-05-02 / Terminated / root cause: labeling and UDI

FDA source

Meretek Diagnostics, Inc. began a recall of BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO on 2007-05-02. The reason FDA records is "Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0003-2008
Status: Terminated
Initiated: 2007-05-02
Posted: 2007-10-04
Terminated: 2007-11-26
Recalling firm: Meretek Diagnostics, Inc.
Product: BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.
Product code: MSQ Test, Urea (Breath Or Blood)
Reason for recall: Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Customers were notified by letter on 05/02/2007 and asked to remove the software program from any computers on which it had been installed and return the software disc and User's Guide to Meretek.
Quantity in commerce: 92 units
Distribution: Nationwide.
Product codes and lots: Version 1.3.5 - January 1, '03

Product code MSQ

K014225Class IBreathtek - Ubit Ubt for H. PyloriMeretek Diagnostics, Inc. / cleared 2002-01-17

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)