Device Recall Roche cobas e 601 module

  • Model / Serial
    1848-01, 1848-03, 1848-04, 185503, 1845-15, 186211, 1857-12, 186225, 1862-16, 1862-10, 185715, 185817, 1865-05, 1862-27, 1858-35, 1859-30, 1859-33, 1863-05, 1867-14, 1844-16, 1868-14, 1844-15, 1870-06, 1870-14, 1857-13, 1870-05, 1868-08, 1867-16, 1868-02, 1865-04, 1867-13, 1862-24, 1872-14, 1872-15, 1871-05, 1873-05, 1871-12, 1871-14, 1873-10, 1872-01, 1871-09, 187015, 1873-01, 1871-04, 187113, 187202, 1871-07, 1873-02, 1866-13, 185731, 1867-20, 1868-01, 01873-03, 1874-06, 1872-12, 1867-19, 1985-08, 1872-07, 1874-05, 1983-10, 1983-09, 1872-03, 1871-01, 1867-06, 1844-14, 1985-10, 187102, 1988-08, 1872-06, 1871-03, 1988-02, 1984-05, 1985-07, 1987-14, 1871-11, 187018, 198703, 1990-04, 1987-04, 1983-08, 199902, 1870-16, 1990-02, 1991-08, 1852-15, 1984-01, 198803, 199110, 198711, 1987-10, 199010, 1988-11, 1991-18, 1990-05, 1988-14, 1991-09, 1991-11, 199112, 1991-13, 1991-14, 1988-10, 1910-02, 1909-09, 1909-10, 1991-15, 1910-03, 1910-05, 190914, 1991-17, 1991-16, 1985-06, 1919-05, 1909-08, 1983-06, 1924-11, 0761-08, 1912-20, 198709, 191007, 1911-11, 1924-12, 0756-30, 1908-03, 1910-06, 1909-13, 1907-02, 1901-15, 1913-03, 1913-04, 1909-01, 1988-06, 1925-07, 192506, 1928-02, 190515, 1905-16, 1924-17, 1924-15, 1905-17, 1924-14, 1927-19, 1907-01, 1931-09, 190520, 1923-17, 1919-07, 1919-08, 1925-11, 1990-08, 1926-04, 2039-11, 2037-08, 1925-12, 1926-02, 0753-22, 1905-11, 1905-18, 1905-19, 1935-17, 1927-09, 2037-13, 1935-16, 1926-03, 190703, 1871-06, 2037-14, 1936-14, 1928-19, 192418, 1936-09, 1936-08, 1991-07, 1919-03, 1911-15, 1935-14, 1927-15, 1924-16, 1924-13, 2039-07, 1928-01, 2037-03, 191305, 1927-16, 2039-12, 192707, 2039-13, 2041-16, 2037-11, 1927-03, 1935-19, 1931-11, 2039-09, 2037-19, 2037-07, 2049-21, 2047-10, 2041-12, 2047-07, 2049-16, 2054-11, 192509, 2041-18, 2047-06, 2049-15, 2051-33, 2051-34, 2049-28, 0763-03, 1914-14, 192717, 2049-14, 2048-31, 2051-32, 2056-09, 2056-12, 2048-05, 2048-32, 2050-31, 2050-32, 2058-22, 2056-14, 2054-06, 2050-29, 2054-10, 1935-18, 2042-01, 2052-05, 2055-30, 2059-11, 2047-09, 2055-35, 2058-23, 2058-32, 2059-28, 2054-07, 2054-08, 2056-10, 2056-13, 2057-28, 2059-15, 2057-36, 2041-09, 0763-01, 1914-12, 2037-09, 0763-05, 1914-16, 0761-07, 1912-19, 1919-02, 1919-04, 2049-29, 2049-30, 1914-11, 2059-16, 2059-17, 2058-21, 2058-25, 2066-32, 2064-12, 2059-12, 2048-06, 2048-29, 2050-28, 2069-08, 2058-18, 2066-38, 2070-05, 2058-17, 2058-20, 2067-32, 2067-33, 1914-18, 2070-22, 2061-21, 2066-35, 2066-36, 2060-25, 2066-39, 2059-40, 2073-21, 2073-25, 2062-02, 1914-19, 2061-29, 2064-06, 2067-29, 2064-13, 2071-26, 2071-27, 2073-38, 2069-24, 2073-19, 2059-10, 2061-34, 2064-05, 2059-05, 2059-23, 2062-14, 2074-05, 2073-16, 2073-18, 2074-04, 2067-30, 2070-40, 2074-01, 2070-18, 2073-10, 2068-33, 2070-17, 2074-30, 2073-09, 2074-25, 2074-17, 2066-22, 2066-23, 2069-01, 2073-12, 2080-26, 2080-30, 2079-32, 2073-15, 2073-40, 2080-19, 2079-40, 2086-35, 2079-27, 2079-36, 2087-03, 2080-35, 2079-30, 2079-34, 2087-07, 2080-13, 2192-16, 2087-09, 2086-40, 2080-11, 2080-17, 2080-25, 2080-24, 1914-17, 2193-11, 763-06, 2070-11, 2070-13, 2085-36, 2085-38, 2066-28, 2070-07, 2079-29, 2080-28, 2195-40, 2195-34, 2195-24, 2192-15, 2192-02, 2196-07, 2192-08, 2195-06, 2087-08, 2073-27, 2079-39, 2077-40, 2078-21, 2085-30, 2087-11, 2192-11, 2192-13, 2196-03, 2102-33, 2195-01, 2195-08, 2104-02, 2195-36, 2086-36, 2067-31, 2106-15, 2106-10, 2190-39, 2191-05, 2190-38, 2195-10, 2106-20, 2066-27, 2102-31, 0884-02, 2047-37, 2102-30, 2195-38, 2196-01, 2192-10, 2102-34, 2106-17, 2104-21, 2102-36, 2103-35, 2077-38, 2078-20, 2107-18, 2103-40, 2104-04, 2107-20, 2103-36, 2104-07, 0802-01, 2061-40, 2107-11, 2107-13, 2072-19, 2107-03, 0801-27, 2061-36, 2102-29, 2192-37, 2196-02, 2103-29, 2072-26, 2072-37, 2107-02, 2104-08, 2104-20, 2107-22, 2107-23, 2071-34, 2193-39, 2072-31, 2108-36, 2104-06, 2194-05, 2072-18, 2107-05, 2072-39, 2104-03, 2072-29, 2072-30, 2108-31, 2108-32, 2107-30, 2107-35, 2107-32, 2108-02, 2107-29, 2108-27, 2108-25, 2108-26, 2137-06, 2108-05, 2108-21, 2072-40, 2107-38, 2137-05, 2137-03, 2137-04, 2137-12, 2137-13, 2107-31, 2137-10, 2137-16, 0884-03, 2047-38, 2108-37, 2137-07, 2137-09, 2137-14, 2072-28, 2137-15, 2144-13, 2137-18, 2137-17, 2145-17, 0801-28, 0801-29, 2061-37, 2061-38, 2145-16, 2145-13, 2140-06, 2140-07, 2073-01, 2111-04, 2145-11, 2145-12, 2145-14, 2145-15, 2140-04, 2135-17, 2140-11, 2149-13, 2086-27, 2140-12, 2148-15, 2149-14, 2148-16, 2145-09, 2145-10, 0829-20, 2086-31, 2148-09, 2149-20, 2149-12, 2256-16, 2256-18, 2256-15, 2140-08, 2140-10, 2250-01, 2256-17, 2071-40, 2256-19, 2148-14, 2149-08, 2257-02, 2256-20, 2257-01, 0829-17, 2086-28, 2250-02, 2250-08, 2256-14, 2288-03, 2288-12, 2288-08, 2290-12, 2293-05, 2288-04, 2288-06, 2202-07, 2288-10, 2202-11, 2292-17, 2202-06, 2288-07, 2209-19, 2227-11, 2208-17, 2227-10, 2207-08, 2226-09, 2212-12, 2212-13, 0817-20, 2075-40, 2209-09, 2209-10, 2227-07, 2227-02, 2227-12, 2227-13, 2226-19, 2227-14, 2226-16, 2226-18, 2224-17, 1005-29, 2228-15, 2219-20, 2218-14, 2220-06, 2219-17, 2229-14, 2219-18, 2212-19, 2212-20, 2233-12, 2233-14, 2221-03, 2234-07, 2219-19, 2225-01, 2224-15, 2233-16, 2229-10, 2233-19, 2229-03, 2229-07, 2229-12, 2233-20, 2224-16, 1008-10, 2234-08, 2234-09, 2236-10, 2234-06, 0817-18, 0817-19, 2075-38, 2075-39, 2234-04, 1118-08, 2358-14, 2234-03, 2232-18, 2234-02, 2220-02, 2220-04, 2220-07, 2232-19, 2230-14, 2230-18, 2233-15, 2232-20, 2234-01, 2347-16, 1118-12, 2230-19, 2230-20, 2348-17, 2233-17, 2232-13, 2232-14, 2232-15, 2233-18, 2348-20, 1987-12, 2240-13, 2240-15, 2356-01, 2348-12, 2348-13, 2347-15, 2348-16, 2368-13, 2369-13, 1118-11, 2347-09, 2347-10, 2358-17, 2347-04, 2367-10, 2369-02, 2237-18, 2240-09, 2240-10, 2367-11, 2367-12, 2369-04, 2369-03, 2355-01, 2367-14, 2367-15, 2368-20, 2369-01, 2347-11, 2367-09, 2382-07, 2382-12, 2382-05, 2385-02, 2385-03, 2347-19, 2348-11, 2398-14, 2304-12, 2379-14, 2381-02, 2381-03, 2382-04, 2382-06, 2379-13, 2350-04, 2384-20, 2385-01, 1122-18, 2304-13, 2362-19, 2367-13, 2398-17, 2384-12, 2384-18, 2399-09, 2399-13, 2399-08, 2398-15, 2398-16, 2305-10, 2304-29, 2305-09, 2395-28, 2369-06, 2313-17, 2307-05, 2399-04, 2304-14, 2304-15, 2396-01, 2305-22, 1122-19, 2362-20, 2396-18, 2304-30, 2305-08, 2310-08, 2327-12, 2327-24, 2301-05, 2308-06, 2311-07, 2311-11, 2395-29, 2311-12, 2311-13, 2396-02, 2327-25, 2327-11, 2396-07, 1122-20, 2319-06, 2363-01, 2327-23, 2398-05, 1128-16, 2368-03, 2312-27, 2396-04, 2399-06, 2328-02, 2327-26, 2321-20, 2305-23, 2307-04, 2332-10, 2307-26, 2307-27, 2332-04, 2332-09, 1128-17, 2368-04, 2321-26, 2328-05, 2332-20, 2321-25, 2332-11, 2332-12, 2317-18, 2396-13, 2398-06, 2322-08, 2321-29, 2312-26, 2312-28, 2399-05, 2399-07, 1128-19, 2368-06, 2321-22, 2321-23, 2321-24, 2328-03, 2437-13, 2437-17, 2437-18, 2438-04, 2438-13, 2437-19, 2437-20, 2321-21, 1128-18, 2368-05, 2226-17, 2439-12, 2438-15, 2438-16, 2439-14, 2444-08, 2444-07, 1159-20, 2306-05, 2446-14, 2446-16, 2467-03, 1159-17, 1159-18, 2306-02, 2306-03, 2467-05, 2479-08, 1159-19, 2306-04, 2441-10, 2441-11, 2438-14, 1142-15, 2389-13, 1142-14, 2389-12, 2446-17, 2446-19, 2450-17, 2451-01, 2439-13, 2469-04, 2451-02, 2451-06, 2451-09, 2468-18, 2444-14, 2486-21, 2473-01, 2451-19, 2479-09, 2479-11, 2472-19, 2468-17, 2486-23, 2446-13, 2451-17, 2452-01, 2469-06, 2479-10, 2451-18, 2469-05, 2469-07, 2486-22, 2473-04, 2473-06, 2486-24, 2489-30, 2472-10, 2481-09, 2472-11, 2472-12, 2473-02, 2473-03, 2467-15, 2486-06, 2473-07, 2485-28, 1142-16, 2389-14, 2486-02, 2472-08, 2472-09, 2485-30, 2493-08, 2486-07, 1142-18, 2389-16, 2486-05, 2485-29, 2487-28, 2493-17, 2488-03, 2493-13, 2493-15, 2486-17, 1142-17, 2389-15, 2486-18, 2446-12, 2493-05, 2493-19, 2486-14, 2486-15, 2486-04, 2486-16, 2402-29, 2493-25, 2488-07, 2403-21, 2493-24, 2402-28, 2488-01, 2493-26, 2488-05, 2493-27, 2488-02, 2497-17, 2493-18, 2487-30, 2402-30, 2493-28, 2497-01, 2486-27, 2493-04, 2496-21, 2384-19, 2497-16, 1142-19, 2493-30, 2494-27, 2486-11, 2486-12, 2486-13, 2389-18, 2497-14, 2497-02, 2497-03, 2494-23, 2494-24, 2494-25, 2494-26, 2402-05, 1263-18, 2429-28, 1925-13, 2495-02, 2494-28, 2497-15, 2493-29, 2495-01, 2402-04, 2402-06, 2497-10, 1908-10, 2414-14, 2405-26, 2497-09, 2406-25, 1263-19, 2429-29, 2047-39, 2406-27, 2497-12, 2407-06, 2494-22, 2414-09, 2494-30, 2497-13, 2413-14, 2414-13, 2406-29, 2407-04, 2422-16, 2413-15, 2406-28, 2413-12, 2413-13, 2405-28, 2405-29, 2413-10, 2422-15, 2413-09, 2422-29, 2494-29, 2423-19, 2413-01, 2413-04, 2422-17, 2414-10, 2414-11, 2414-12, 1263-20, 2413-11, 2429-30, 2423-22, 2369-05, 2047-36, 2422-28, 2423-20, 2413-02, 2413-03, 2422-18, 2425-12, 1377-13, 2539-07, 2425-14, 1377-12, 2423-15, 2539-06, 2493-23, 2494-21, 2422-19, 2423-16, 2423-17, 2427-30, 2428-01, 2422-23, 2422-24, 2430-30, 2431-21, 2431-22, 2413-08, 2423-14, 2427-14, 2427-15, 2427-29, 2430-27, 2430-29, 2427-13, 2431-26, 2431-23, 1377-14, 2428-02, 2539-08, 2423-21, 2425-13, 2430-28, 2431-24, 2431-25, 2427-25, 2427-26, 2423-18, 2535-22, 2427-27, 1914-20, 2427-22, 2423-03, 2423-04, 2425-11, 2427-18, 2427-21, 1914-15, 2535-21, 2423-05, 1910-04, 2535-23, 2535-05, 2432-27, 2535-18, 2427-28, 2535-20, 2535-08, 1383-03, 2427-23, 2427-24, 2544-21, 2534-04, 2427-16, 2427-17, 2534-03, 2427-19, 2427-20, 2535-09, 2535-10, 2535-11, 2533-21, 2535-12, 2535-13, 2535-14, 1387-16, 2458-23, 2534-05, 2534-06, 2432-24, 2535-06, 2535-07, 2432-29, 2432-30, 2408-22, 2409-22, 2497-22, 2538-28, 2432-22, 2432-23, 2408-20, 1383-04, 2544-22, 2497-21, 2543-10, 2540-23, 2540-24, 2550-04, 2432-26, 2432-28, 2409-26, 2538-29, 2548-02, 2409-24, 2409-25, 2548-03, 2408-23, 2409-23, 2432-25, 2543-04, 2550-10, 2550-11, 2564-21, 2564-22, 2543-03, 2567-22, 2543-08, 2543-09, 2547-30, 2548-01, 2543-11, 2543-12, 13A1-02, 2560-03, 2565-27, 2567-21, 2550-18, 2547-29, 2550-12, 2550-14, 2565-25, 2565-26, 2488-04, 2576-22, 2567-23, 2550-19, 2581-18, 2550-15, 2564-23, 2565-24, 13A9-08, 2570-29, 2565-23, 2565-28, 2581-17, 2564-30, 2565-21, 2565-22, 2581-25, 2587-14, 184826, 2585-04, 2581-26, 13A9-09, 2570-30, 2585-27, 1387-17, 2548-24, 2576-21, 2577-01, 2577-02, 2587-10, 192706, 1855-33, 1927-20, 2580-28, 2580-29, 2580-27, 2587-11, 2587-12, 2564-29, 2566-26, 2581-21, 2581-19, 2581-20, 2585-25, 2566-25, 2566-30, 2587-13, 2585-20, 2563-30, 2585-05, 2585-24, 2108-30, 2566-28, 2566-29, 2581-24, 2585-23, 2566-27, 13B8-10, 2550-16, 2563-29.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) || Product Usage: || Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
  • Source
    USFDA