Events

Retiro De Equipo (Recall) de Device Recall Roche cobas e 601 module

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Roche Diagnostics Operations, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68294
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1791-2014
  • Fecha de inicio del evento
    2014-05-21
  • Fecha de publicación del evento
    2014-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127316
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Under certain conditions loose procell/cleancell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
  • Acción
    Roche sent an Urgent Medical Device Correction (UMDC) letter dated May 20, 2014 via UPS Grount (receipt required) to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Follow the instructions in the Precautions Regarding Handling the Aspiration Tube Filter section in this UMDC; 2. Discontinue performing ProCell/Clean Cell aspiration tube filter check as this maintenance item will be performed by your Roche FSR as a part of service maintenance; 3. If you have distributed the products listed within this UMDC to other sites or facilities, please provide them with a copy of the UMDC; and 4. Complete the faxback form enclosed with this UMDC and fax it to 1-888-410-6620. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

Device

Device Recall Roche cobas e 601 module
  • Modelo / 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, 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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, 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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, 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  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    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
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA