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FAQ
Crédits
Devices
Device Recall VITEK 2 Gram Negative test kit containing colistin (cs01n)
Modèle / numéro de série
REF # (Description): 418114 (AST-GN94), 22258 (AST-N102), 412605 (AST-N194), 412921 (AST-N199), 412862 (AST-N201), 412863 (AST-N202), 412924 (AST-N205), 412918 (AST-N210), 413061 (AST-N212), 413083 (AST-N222), 413112 (AST-N225), 413171 (AST-N236), 413172 (AST-N237), 413204 (AST-N239), 413205 (AST-N240), 413391 (AST-N242), 413394 (AST-N245), 413397 (AST-N248), 413572 (AST-N249), 413722 (AST-N253), 413724 (AST-N255), 413725 (AST-N256), 413753 (AST-N261), 414164 (AST-N272), 414286 (AST-N276), 414492 (AST-N279), 414531 (AST-N280), 414532 (AST-N281), 414972 (AST-N288), 415063 (AST-N292), 415369 (AST-N293), 415433 (AST-N295), 416005 (AST-N299), 416241 (AST-N300), 416590 (AST-N303), 416913 (AST-N308), 416914 (AST-N309), 417426 (AST-N315), 417952 (AST-N318), 418204 (AST-N320), 418489 (AST-N322), 418513 (AST-N235), 418514 (AST-N326), 418630 (AST-N328), 418631 (AST-N329), 418675 (AST-N331), 418676 (AST-N332), 418985 (AST-N335), 419077 (AST-N338), 419341 (AST-N339), 420063 (AST-N343), 420440 (AST-N344), 420867 (AST-N347), 420856 (AST-N348), 421258 (AST-N352), 421297 (AST-N353), 421350 (AST-N354), 421351 (AST-N355, 421451 (AST-N357), 421441 (AST-N358), 421583 (AST-N360), 421584 (AST-N361), 421585 (AST-N362), 421692 (AST-363), 421693 (AST-N364), 421830 (AST-N365), 421853 (AST-N366), 421854 (AST-N367), 421855 (AST-N368), 410025 (AST-XN01), 413230 (AST-XN05)
Classification du dispositif
Immunology and Microbiology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Domestic: NC. Foreign: Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Netherlands Antilles, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, & Vietnam.
Description du dispositif
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Manufacturer
Biomerieux Inc
1 Event
Rappel de Device Recall VITEK 2 Gram Negative test kit containing colistin (cs01n)
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Fabricant
Biomerieux Inc
Adresse du fabricant
Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
Société-mère du fabricant (2017)
Compagnie Merieux Alliance
Source
USFDA
Language
English
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