Recall: Antibiotic Efficacy Test May Report False Results
bioMerieux announced a recall of the Etest PIP/TAZO/CON-4 PTC 256 because the test results may indicate that therapy with PIP/TAZO can stop or slow the growth of certain bacteria when it may not be effective in treating those bacteria.
The Etest PIP/TAZO/CON-4 256 is used to help predict if the antibiotic combination piperacillin/tazobactam (PIP/TAZO) will be effective in treating serious infections.
The resulting error can lead to inappropriate treatment of a patient's infection and can cause serious consequences, including increased duration of hospital stay, unnecessary tests or procedures, treatment failure, sepsis, and even death.
The affected products include manufacturing dates of December 20, 2012 to October 23, 2015 with distribution dates of January 24, 2013 to November 9, 2015. The full list of reference and lot numbers are listed here. The Company has sent Urgent Product Removal Notices to customers with instructions on discontinuing the product and discarding remaining inventory.
For more information call (800) 682-2566 or visit FDA.gov.