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

[Posted 12/29/2015]

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:

• Review the notification and ensure appropriate laboratory personnel are aware of the notice.
• Stop using the affected product and discard any remaining inventory of the affected product.
• Discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.
• Complete and return the Acknowledgement Form by fax to confirm receipt of the notice.
• Questions should be directed to bioMérieux’s Customer Care Center: 1-800-682-2666, Monday through Friday between the hours of 7 a.m. and 7 p.m. Eastern Standard Time.

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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[12/29/2015 - Recall Notice - FDA]