The French biotechnology company bioMérieux has recalled the Etest PIP/TAZO/CON-4 PTC 256 because test results from the affected product may indicate that antibiotic therapy using Piperacillin/Tazobactam (PIP/TAZO) could stop or slow the growth of certain bacteria when it may not actually be effective in treating those bacteria.
The Food and Drug Administration (FDA) notification explains that the error may result in inappropriate treatment of a patient’s infection and could cause serious health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death.
This is a Class 1 recall, the FDA’s most serious category, reserved for situations that may result in serious injury or death.
The Etest PIP/TAZO/CON-4 PTC 256 is used by health care providers to help predict if the antibiotic PIP/TAZO will be effective in treating serious infections.
This recall includes all products with manufacturing dates December 20, 2012 to October 23, 2015, and distribution dates: January 24, 2013 to November 9, 2015. The products were distributed nationwide. The recall notice on the FDA website has a listing of affected product numbers and lot numbers.
Beginning November 24, 2015, bioMérieux sent an Urgent Product Removal Notice to customers. The letter advised customers to
- 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 about previously reported results with the laboratory medical director to determine the appropriate course of action.
Customers may direct their questions to bioMérieux’s Customer Care Center: 1-800-682-2666, Monday through Friday from 7 a.m. to 7 p.m. Eastern Standard Time.