FDAClass IDecember 30, 2015

Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. recall

Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of…

Why was Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Ref. 412433, Lot numbers: 1004394540, 1003903640, 1003558430, 1003069250, 1002372580 and 1001938220

Product
Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of…
Recalling firm
Biomerieux
Quantity
1216 units
Distribution
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.
Recall date
December 30, 2015
Classification
Class I
Status
Terminated
Agency
FDA (device)
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