Events

Recall of Device Recall Roche cobas e 601 module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68294
  • Event Risk Class
    Class 2
  • Event Number
    Z-1791-2014
  • Event Initiated Date
    2014-05-21
  • Event Date Posted
    2014-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127316
  • Notes / Alerts
    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.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Under certain conditions loose procell/cleancell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
  • Action
    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
  • 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, 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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, 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, 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  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    Roche Diagnostics Operations, Inc.

Manufacturer

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