FDA MedWatch - Etest PIP/TAZO/CON-4 PTC 256 by bioMérieux: Class I Recall – Potential for Test Result Error

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Title: FDA MedWatch - Etest PIP/TAZO/CON-4 PTC 256 by bioMérieux: Class I Recall – Potential for Test Result Error
MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

 

Etest PIP/TAZO/CON-4 PTC 256 by bioMérieux: Class I Recall – Potential for Test Result Error

AUDIENCE: Health Professional, Infectious Disease, Patient

ISSUE: bioMérieux recallied the Etest PIP/TAZO/CON-4 PTC 256 because the test results from the affected product may indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria when it may not actually be effective in treating those bacteria. This error may result in inappropriate treatment of a patient’s infection and could cause serious patient health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death.

This recall includes all affected products with manufacturing dates December 20, 2012 to October 23, 2015, and distribution dates: January 24, 2013 to November 9, 2015. See the Recall Notice for a listing of affected product reference and lot numbers.

BACKGROUND: The Etest PIP/TAZO/CON-4 PTC 256 is used by health care providers to help predict if the antibiotic Piperacillin/Tazobactam (PIP/TAZO) will be effective in treating serious infections.

RECOMMENDATION: bioMérieux sent an Urgent Product Removal Notice to customers beginning on November 24, 2015. The letter issued the following instructions:

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Read the MedWatch safety alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm479208.htm


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