Company Recalls Infection Test

Erroneous results may lead to treatment failure and death

The Etest PIP/TAZO/CON-4 PTC 256 has been recalled by bioMérieux because the 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. 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 ranging from December 20, 2012, to October 23, 2015, and distribution dates ranging from January 24, 2013, to November 9, 2015.

The Etest PIP/TAZO/CON-4 PTC 256 is used by health care providers to help predict whether PIP/TAZO will be effective in treating serious infections.

Beginning on November 24, 2015, bioMérieux sent an urgent product removal notice to customers with 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 the institution’s laboratory medical director to determine the appropriate course of action.
  • Complete and return the acknowledgement form by fax to confirm receipt of the notice.

Source: FDA; December 29, 2015.