United StatesWhat's being recalled
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only
Recalling firm: bioMerieux, Inc., Durham, NC, United States.
How to identify it
Material Number/Material Description/Batch Number: 423936 AST-N412 TEST KIT 20 CARDS 0143139204 423936 AST-N412 TEST KIT 20 CARDS 0143254504 423936 AST-N412 TEST KIT 20 CARDS 0143303504 424196 AST-N427 TEST KIT 20 CARDS 0542849204 424196 AST-N427 TEST KIT 20 CARDS 0543190104 424196 AST-N427 TEST KIT 20 CARDS 0543266504 424196 AST-N427 TEST KIT 20 CARDS 0542951404 424196 AST-N427 TEST KIT 20 CARDS 0543190104 424196 AST-N427 TEST KIT 20 CARDS 0543289404 424499 AST-N438 TEST KIT 20 CARDS 0703181504 424499 AST-N438 TEST KIT 20 CARDS 0703218104 424499 AST-N438 TEST KIT 20 CARDS 0703273104 424499 AST-N438 TEST KIT 20 CARDS 0703125104 424501 AST-N439 TEST KIT 20 CARDS 0723192104 424501 AST-N439 TEST KIT 20 CARDS 0723048404 424501 AST-N439 TEST KIT 20 CARDS 0722971504 424501 AST-N439 TEST KIT 20 CARDS 0723237504 424501 AST-N439 TEST KIT 20 CARDS 0722860204 424502 AST-N440 TEST KIT 20 CARDS 0733170404 424502 AST-N440 TEST KIT 20 CARDS 0733317504 424502 AST-N440 TEST KIT 20 CARDS 0733170404 424541 AST-N443 TEST KIT 20 CARDS 0773230404 424541 AST-N443 TEST KIT 20 CARDS 0773247404 424541 AST-N443 TEST KIT 20 CARDS 0772911104 424587 AST-N444 TEST KIT 20 CARDS 0802553214 424587 AST-N444 TEST KIT 20 CARDS 0802553204 424620 AST-N447 TEST KIT 20 CARDS 0853198104 424620 AST-N447 TEST KIT 20 CARDS 0853247204 424633 AST-N448 TEST KIT 20 CARDS 0862971204 424633 AST-N448 TEST KIT 20 CARDS 0863202504 424633 AST-N448 TEST KIT 20 CARDS 0863296504 424839 AST-N462 TEST KIT 20 CARDS No Lots 424840 AST-N463 TEST KIT 20 CARDS No Lots 424842 AST-N465 TEST KIT 20 CARDS No Lots 424891 AST-N475 TEST KIT 20 CARDS 1703184204 424891 AST-N475 TEST KIT 20 CARDS 1703225504 424934 AST-N476 TEST KIT 20 CARDS 1713192504 425019 AST-N477 TEST KIT 20 CARDS 1733184104 425019 AST-N477 TEST KIT 20 CARDS 1733205204 425019 AST-N477 TEST KIT 20 CARDS 1733205214 424197 AST-XN21 TEST KIT 20 CARDS 0493174204 424197 AST-XN21 TEST KIT 20 CARDS 0493310504 424199 AST-XN22 TEST KIT 20 CARDS 0552981204 424199 AST-XN22 TEST…
The hazard
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkey.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada