Monday, 08 February 2016 13:43

Recall Of Etest Pip/Tazo/Con-4 Ptc 256 By Biomerieux

This is to bring to your notice important safety information for Etest PIP/TAZO/CON-4 PTC 256 manufactured by BioMerieux. The device aids healthcare providers predict effectiveness of the antibiotic combination PIP/TAZO (Piperacillin/Tazobactam) in treating serious infections.

Reason for Recall

  • Test results from Etest PIP/TAZO/CON-4 PTC 256 products may indicate that antibiotic therapy using PIP/TAZO could prove effective in the slowing or stopping of susceptive bacterial growth while in practice; it might prove ineffective.

Possible Risks

  • As a result of the device’s error, there may be delayed treatment of infection as the sub-effective antibiotics may be administered for longer durations in order to eliminate the bacterial load.
  • Treatment failure, sepsis or even death could result from administration of an ineffective antibiotic for a serious infection.

Information on Product Details                                               

  • Manufacturer –BioMerieux
  • Product - Etest PIP/TAZO/CON-4 PTC 256
  • Affected Range - All with manufacturing dates between Dec 20, 2012 to Oct 23, 2015 and distribution dates between Jan 24, 2013 to Nov 9, 2015.

Healthcare Provider’s action

  • Healthcare providers should be aware of the recall, inform all laboratory personnel and discontinue the use of the recalled products.
  • Report all serious adverse events or side effects related to the use of this device to NAFDAC PRASCOR (20543 – Toll free from all network) or via individual case safety report forms or via email : This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC… Safeguarding the health of the Nation!

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