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Terminated

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

FDA Recall Z-0003-2008 · Posted 2007-10-04

Recalling FirmMeretek Diagnostics, Inc.
Recall StatusTerminated
Product CodeMSQ
Date Initiated2007-05-02
Date Terminated2007-11-26
Product Quantity92 units

Reason for Recall

Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014225BREATHTEK - UBIT UBT FOR H. PYLORIMeretek Diagnostics, Inc. · 2002-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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