Medical Devices

bioMérieux SA Etest® PIP/TAZO/CON-4 PTC 256 – Potential for Test Result Error

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product:

  • Etest® Piperacillin/Tazobactam 4mg/mL PTC 0.016-256 (PIP/TAZO/CON-4 PTC 256)
  • All affected products
  • Manufacturing Dates: December 20, 2012 to October 23, 2015
  • Distribution Dates: January 24, 2013 to November 9, 2015
  • Devices Recalled in the U.S.: 3760 Nationwide

Device Use: The Etest® PIP/TAZO/CON-4 PTC 256 is used by health care providers to help predict if the antibiotic Piperacillin/Tazobactam (PIP/TAZO) will be effective in treating serious infections.

Reason for Recall: bioMérieux is recalling the Etest® PIP/TAZO/CON-4 PTC 256 because the test results from the affected product may indicate that antibiotic therapy using 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.

Who may be affected:

  • Patients who had the Etest® PIP/TAZO/CON-4 PTC 256
  • Health care providers who refer patients for the Etest® PIP/TAZO/CON-4 PTC 256
  • Laboratory personnel who interpret the results of the Etest® PIP/TAZO/CON-4 PTC 256

What to Do: bioMérieux sent an Urgent Product Removal Notice to customers beginning on November 24, 2015.

The letter issued the following instructions:

  1. Review the notification and ensure appropriate laboratory personnel are aware of the notice.
  2. Stop using the affected product and discard any remaining inventory of the affected product.
  3. Discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.
  4. Complete and return the Acknowledgement Form by fax to confirm receipt of the notice.

Contact Information: Questions should be directed to bioMérieux’s Customer Care Center: 1-800-682-2666, Monday through Friday between the hours of 7 a.m. and 7 p.m. Eastern Standard Time.

Date Recall Initiated: November 24, 2015

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Full List of Affected Devices:

Product Reference NumberDescriptionLot Number
412434Etest® PIP/TAZO/CON-4 PTC 256 - pack of 30 tests WW1004331500
1004271120
1004178060
1003977300
1003697470
1003415090
1003276060
1003069230
1002488490
1001936360
412433Etest® PIP/TAZO/CON-4 PTC 256 – pack of 30 tests US1004394540
1003903640
1003558430
1003069250
1002372580
1001938220
521418Etest® PIP/TAZO/CON-4 PTC 256 – Foam of 100 tests WW1004398470
1004276460
1004180840
1003980200
1003699550
1003416920
1003105180
1002995820
1002482640
1002375410
1002276210
1002092270
521458Etest® PIP/TAZO/CON-4 PTC 256 – Foam of 100 tests US1004397280
1004271100
1003977350
1003903650
1003561810
1003239850
1002489700
1002273480
1002216620
1002120370

Devices Distribution:
The affected product was distributed in:

  • Alaska (AK)
  • Alabama (AL)
  • Arkansas (AR)
  • Arizona (AZ)
  • California (CA)
  • Colorado (CO)
  • Connecticut (CT)
  • District of Columbia (DC)
  • Florida (FL)
  • Georgia (GA)
  • Hawaii (HI)
  • Iowa (IA)
  • Illinois (IL)
  • Indiana (IN)
  • Kansas (KS)
  • Kentucky (KY)
  • Louisiana (LA)
  • Maine (MA)
  • Maryland (MD)
  • Michigan (MI)
  • Minnesota (MN)
  • Missouri (MO)
  • Mississippi (MS)
  • Montana (MT)
  • North Carolina (NC)
  • North Dakota (ND)
  • Nebraska (NE)
  • New Hampshire (NH)
  • New Jersey (NJ)
  • New Mexico (NM)
  • Nevada (NV)
  • New York (NY)
  • Ohio (OH)
  • Oklahoma (OK)
  • Oregon (OR)
  • Pennsylvania (PA)
  • Rhode Island (RI)
  • South Carolina (SC)
  • South Dakota (SD)
  • Tennessee (TN)
  • Texas (TX)
  • Virginia (VA)
  • Vermont (VT)
  • Washington (WA)
  • Wisconsin (WI)
  • West Virginia (WV)
  • Wyoming (WY)

 

Page Last Updated: 12/29/2015
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