Monday, 08 February 2016 13:43

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

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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!

Read 11770 times Last modified on Wednesday, 18 May 2016 14:16

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