Z-1791-2014Class II
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001...
Roche Diagnostics GmbH / initiated 2014-05-21 / Terminated / root cause: labeling and UDI
Roche Diagnostics Operations, Inc. began a recall of cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully... on . FDA classified it as Class II and gives the reason as "Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1791-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Roche Diagnostics GmbH
- Product
- 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.
- Product code
- JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Reason for recall
- Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling design
- 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.
- Quantity in commerce
- 1147
- Distribution
- US Nationwide Distribution
- Product codes and lots
- 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, 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Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1790-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1791-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1792-2014 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.