Test Used to Predict Effectiveness of Antibiotic RecalledDec 31, 2015
A recall has been issued for bioMérieux's Etest PIP/TAZO/CON-4 PTC 256, a test that health care professionals use to predict whether the antibiotic Piperacillin/Tazobactam (PIP/TAZO) will be successful in treating serious infections, the U.S. Food and Drug Administration (FDA) said. The product was recalled because the test may be inaccurate when indicating that PIP/TAZO therapy could be effective at fighting bacterial growth. "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." the notification states.
The recall was designated as Class I, the FDA's most serious recall status. Class I recalls mean that exposure to the recalled product present a reasonable risk of serious injury or death.
bioMérieux notified customers about the recall on November 24, 2015. Customers were advised to stop using the product and dispose any remaining ones. The company can be contacted at 1-800-682-2666, Monday through Friday between the hours of 7 a.m. and 7 p.m. Eastern Standard Time.