Medical Device Recall: Z-0003-2008

FDA Recalls dataset · Firm: Meretek Diagnostics, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2007-05-02 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0003-2008.

Recall Res Number
Z-0003-2008
Recalling Firm / Manufacturer
Meretek Diagnostics, Inc.
FEI Number
3000210499
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2007-05-02
Date Posted
2007-10-04
Date Terminated
2007-11-26
Product Code
MSQ
Event Number
38430
Product Quantity
92 units
Product Description BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.
Reason for Recall Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.
Action Details 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.
Distribution Pattern Nationwide.
Code Information / Serial Numbers Version 1.3.5 - January 1, '03

Related Establishments / Registrations

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