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Biomerieux Inc

514 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
VITEK 2 Gram Negative Susceptibility card (AST-N255), REF 413724, 20 cards per carton. recall (Z-2436-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-P625), REF 413727, 20 cards per carton. recall (Z-2437-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N263), REF 413755, 20 cards per carton. recall (Z-2438-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N264), REF 413864, 20 cards per carton. recall (Z-2439-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N265), REF 413865, 20 cards per carton. recall (Z-2440-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N268), REF 413868, 20 cards per carton. recall (Z-2441-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-GN74), REF 413941, 20 cards per carton. recall (Z-2442-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-GN86), REF 413942, 20 cards per carton. recall (Z-2443-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-GN87), REF 413943, 20 cards per carton. recall (Z-2444-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-XN06), REF 413944, 20 cards per carton. recall (Z-2445-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N270), REF 414162, 20 cards per carton. recall (Z-2446-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N271), REF 414163, 20 cards per carton. recall (Z-2447-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N272), REF 414164, 20 cards per carton. recall (Z-2448-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N276), REF 414286, 20 cards per carton. recall (Z-2449-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N275), REF 414313, 20 cards per carton. recall (Z-2450-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N279), REF 414492, 20 cards per carton. recall (Z-2451-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N281), REF 414532, 20 cards per carton. recall (Z-2452-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P628), REF 414534, 20 cards per carton. recall (Z-2453-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P629), REF 414576, 20 cards per carton. recall (Z-2454-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N285), REF 414740, 20 cards per carton. recall (Z-2455-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N286), REF 414778, 20 cards per carton. recall (Z-2456-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-GN90), REF 414779, 20 cards per carton. recall (Z-2457-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-GN91), REF 414780, 20 cards per carton. recall (Z-2458-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per carton. recall (Z-2459-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-GN92), IVD, REF 414963, 20 cards per carton recall (Z-2460-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton. recall (Z-2461-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-GP74), REF 414971, 20 cards per carton. recall (Z-2462-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-GN93), REF 414985, 20 cards per carton. recall (Z-2463-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P633), REF 414994, 20 cards per carton. recall (Z-2464-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N290), REF 415058, 20 cards per carton. recall (Z-2465-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P632), REF 415059, 20 cards per carton. recall (Z-2466-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N292), REF 415063, 20 cards per carton. recall (Z-2467-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N293), REF 415369, 20 cards per carton. recall (Z-2468-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-GP75), IVD, REF 415670, 20 cards per carton recall (Z-2469-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P634), IVD, REF 415671, 20 cards per carton recall (Z-2470-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 cards per carton recall (Z-2471-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N298), IVD, REF 416004, 20 cards per carton recall (Z-2472-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N300), IVD, REF 416241, 20 cards per carton recall (Z-2473-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N301), IVD, REF 416274, 20 cards per carton recall (Z-2474-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N303), IVD, REF 416590, 20 cards per carton recall (Z-2475-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P635), IVD, REF 416911, 20 cards per carton recall (Z-2476-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N311), IVD, REF 416952, 20 cards per carton recall (Z-2477-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N314), IVD, REF 417027, 20 cards per carton recall (Z-2478-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N315), IVD, REF 417426, 20 cards per carton recall (Z-2479-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N317), IVD, REF 417558, 20 cards per carton recall (Z-2480-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N320), IVD, REF 418204, 20 cards per carton recall (Z-2481-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P638), IVD, REF 418423, 20 cards per carton recall (Z-2482-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards per carton recall (Z-2483-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N322), IVD, REF 418489, 20 cards per carton recall (Z-2484-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N325), IVD, REF 418513, 20 cards per carton recall (Z-2485-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N327), IVD, REF 418515, 20 cards per carton recall (Z-2486-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P640), IVD, REF 418579, 20 cards per carton recall (Z-2487-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P641), IVD, REF 418590, 20 cards per carton recall (Z-2488-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 cards per carton recall (Z-2489-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N324), IVD, REF 418603, 20 cards per carton recall (Z-2490-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P642), IVD, REF 418604, 20 cards per carton recall (Z-2491-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N328), IVD, REF 418630, 20 cards per carton recall (Z-2492-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N329), IVD, REF 418631, 20 cards per carton recall (Z-2493-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P643), IVD, REF 418671, 20 cards per carton recall (Z-2494-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P644), IVD, REF 418673, 20 cards per carton recall (Z-2495-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N330), IVD, REF 418674, 20 cards per carton recall (Z-2496-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N331), IVD, REF 418675, 20 cards per carton recall (Z-2497-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N334), IVD, REF 418984, 20 cards per carton recall (Z-2498-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N335), IVD, REF 418985, 20 cards per carton recall (Z-2499-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N339), IVD, REF 419341, 20 cards per carton recall (Z-2500-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N340), IVD, REF 419412, 20 cards per carton recall (Z-2501-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P645), IVD, REF 419602, 20 cards per carton recall (Z-2502-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards per carton recall (Z-2503-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N344), IVD, REF 420440, 20 cards per carton recall (Z-2504-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N345), IVD, REF 420580, 20 cards per carton recall (Z-2505-2017)Biomerieux Inc2017-05-22
VITEK 2 Fungal Susceptibility card (AST-YS08), IVD, REF 420739, 20 cards per carton. recall (Z-2506-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N348), IVD, REF 420856, 20 cards per carton recall (Z-2507-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 cards per carton recall (Z-2508-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P649), IVD, REF 420858, 20 cards per carton recall (Z-2509-2017)Biomerieux Inc2017-05-22
VITEK 2 Streptococcus Susceptibility card (AST-ST02), IVD, REF 420915, 20 cards per carton recall (Z-2510-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N350), IVD, REF 421037, 20 cards per carton recall (Z-2511-2017)Biomerieux Inc2017-05-22
VITEK 2 Streptococcus Susceptibility card (AST-ST03), IVD, REF 421040, 20 cards per carton recall (Z-2512-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 cards per carton recall (Z-2513-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N352), IVD, REF 421258, 20 cards per carton recall (Z-2514-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Positive Susceptibility card (AST-P650), IVD, REF 421296, 20 cards per carton recall (Z-2515-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 cards per carton recall (Z-2516-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N354), IVD, REF 421350, 20 cards per carton recall (Z-2517-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 cards per carton recall (Z-2518-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N356), IVD, REF 421352, 20 cards per carton recall (Z-2519-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N358), IVD, REF 421441, 20 cards per carton recall (Z-2520-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per carton recall (Z-2521-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 cards per carton recall (Z-2522-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N362), IVD, REF 421585, 20 cards per carton recall (Z-2523-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N363), IVD, REF 421692, 20 cards per carton recall (Z-2524-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-N364), IVD, REF 421693, 20 cards per carton recall (Z-2525-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 cards per carton. recall (Z-2526-2017)Biomerieux Inc2017-05-22
VITEK 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 cards per carton recall (Z-2527-2017)Biomerieux Inc2017-05-22
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Produ recall (Z-1639-2016)Biomerieux Inc2016-05-11
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Produ recall (Z-1640-2016)Biomerieux Inc2016-05-11
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Produ recall (Z-1641-2016)Biomerieux Inc2016-05-11
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Produ recall (Z-1642-2016)Biomerieux Inc2016-05-11
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Produ recall (Z-1643-2016)Biomerieux Inc2016-05-11
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Produ recall (Z-1644-2016)Biomerieux Inc2016-05-11
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Produ recall (Z-1645-2016)Biomerieux Inc2016-05-11
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Produ recall (Z-1646-2016)Biomerieux Inc2016-05-11
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Every clearance here is in the API, with alerts when new ones post.