CLASS I Device recall · Reported 30 Dec 2015 · FDA Enforcement Report

Etest¿ Pip/Tazo/Con-4 Ptc 256 - Foam of 100 tests US recalled

Biomerieux is recalling Etest¿ Pip/Tazo/Con-4 Ptc 256 - Foam of 100 tests US. Etest¿ is a quantitative, distributed nationwide in the US. The recall was initiated on 19 Nov 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesRef. 521458, Lot numbers: 1004397280, 1004271100, 1003977350, 1003903650, 1003561810, 1003239850, 1002489700, 1002273480, 1002216620 and 1002120370.

Quantity recalled2422 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0442-2016
FDA event ID: 72755
Recalling firm: Biomerieux, Letoile, N/A
Classification: Class I
Status: Terminated
Recall initiated: 19 Nov 2015
FDA classified: 23 Dec 2015
Reported: 30 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Nov 2015	Recall initiated by company
23 Dec 2015	Classified by FDA	+34 days
30 Dec 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.

Product as listed by the FDA

Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

Where it was distributed

Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota

Questions about this recall

Why was it recalled?

Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.

Which lots are affected?

Ref. 521458, Lot numbers: 1004397280, 1004271100, 1003977350, 1003903650, 1003561810, 1003239850, 1002489700, 1002273480, 1002216620 and 1002120370.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 72755

Reported	Class	Recall	Company	Reason	Where
30 Dec 2015	CLASS I	Etest¿ Pip/Tazo/Con-4 Ptc of 30 tests US recalled by Biomerieux	Biomerieux	Other	Nationwide
30 Dec 2015	CLASS I	Etest¿ Pip/Tazo/Con-4 Ptc 256 - Foam of 100 tests WW recalled	Biomerieux	Other	Nationwide
30 Dec 2015	CLASS I	Etest¿ Piperacillin/tazobactam recalled by Biomerieux	Biomerieux	Other	Nationwide

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