EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.
Class I - DangerousWhat Should You Do?
- Check if you have this product: L166A1801 L169A1835 L16XA1869 L171A1903 L173A1937 L174A1971 L166A1802 L169A1836 L16XA1870 L171A1904 L173A1938 L174A1972 L166A1803 L169A1837 L16YA1871 L171A1905 L173A1939 L174A1973 L166A1804 L169A1838 L16YA1872 L171A1906 L173A1940 L174A1974 L166A1805 L169A1839 L16YA1873 L171A1907 L173A1941 L174A1975 L166A1806 L169A1840 L16YA1874 L171A1908 L173A1942 L174A1976 L166A1807 L169A1841 L16YA1875 L171A1909 L173A1943 L174A1977 L166A1808 L169A1842 L16YA1876 L171A1910 L173A1944 L174A1978 L166A1809 L169A1843 L16YA1877 L172A1911 L173A1945 L174A1979 L166A1810 L169A1844 L16YA1878 L172A1912 L173A1946 L174A1980 L167A1811 L169A1845 L16YA1879 L172A1913 L173A1947 L174A1981 L167A1812 L169A1846 L16YA1880 L172A1914 L173A1948 L174A1982 L167A1813 L169A1847 L16YA1881 L172A1915 L173A1949 L174A1983 L167A1814 L169A1848 L16YA1882 L172A1916 L173A1950 L174A1984 L167A1815 L169A1849 L16YA1883 L172A1917 L173A1951 L174A1985 L167A1816 L169A1850 L16YA1884 L172A1918 L173A1952 L174A1986 L167A1817 L16XA1851 L16YA1885 L172A1919 L173A1953 L174A1987 L167A1818 L16XA1852 L16YA1886 L172A1920 L173A1954 L174A1988 L167A1819 L16XA1853 L16YA1887 L172A1921 L173A1955 L174A1989 L167A1820 L16XA1854 L16YA1888 L172A1922 L173A1956 L174A1990 L168A1821 L16XA1855 L16YA1889 L172A1923 L173A1957 L175A1991 L168A1822 L16XA1856 L16YA1890 L172A1924 L173A1958 L175A1992 L168A1823 L16XA1857 L16ZA1891 L172A1925 L173A1959 L175A1993 L168A1824 L16XA1858 L16ZA1892 L172A1926 L173A1960 L175A1994 L168A1825 L16XA1859 L16ZA1893 L172A1927 L174A1961 L175A1995 L168A1826 L16XA1860 L16ZA1894 L172A1928 L174A1962 L175A1996 L168A1827 L16XA1861 L16ZA1895 L172A1929 L174A1963 L175A1997 L168A1828 L16XA1862 L16ZA1896 L172A1930 L174A1964 L175A1998 L168A1829 L16XA1863 L16ZA1897 L173A1931 L174A1965 L175A1999 L168A1830 L16XA1864 L16ZA1898 L173A1932 L174A1966 L175A2000 L169A1831 L16XA1865 L16ZA1899 L173A1933 L174A1967 L175A2001 L169A1832 L16XA1866 L16ZA1900 L173A1934 L174A1968 L175A2002 L169A1833 L16XA1867 L171A1901 L173A1935 L174A1969 L175A2003 L169A1834 L16XA1868 L171A1902 L173A1936 L174A1970 L175A2004 L175A2005 L177A2039 L181A2073 L183A2107 L175A2006 L177A2040 L181A2074 L183A2108 L175A2007 L178A2041 L181A2075 L183A2109 L175A2008 L178A2042 L181A2076 L183A2110 L175A2009 L178A2043 L181A2077 L183A2111 L175A2010 L178A2044 L181A2078 L183A2112 L175A2011 L178A2045 L181A2079 L183A2113 L175A2012 L178A2046 L181A2080 L183A2114 L175A2013 L178A2047 L182A2081 L183A2115 L175A2014 L178A2048 L182A2082 L183A2116 L175A2015 L178A2049 L182A2083 L183A2117 L175A2016 L178A2050 L182A2084 L184A2118 L175A2017 L17ZA2051 L182A2085 L184A2119 L175A2018 L17ZA2052 L182A2086 L184A2120 L175A2019 L17ZA2053 L182A2087 L184A2121 L175A2020 L17ZA2054 L182A2088 L184A2122 L176A2021 L17ZA2055 L182A2089 L184A2123 L176A2022 L17ZA2056 L182A2090 L184A2124 L176A2023 L17ZA2057 L182A2091 L184A2125 L176A2024 L17ZA2058 L182A2092 L184A2126 L176A2025 L17ZA2059 L182A2093 L184A2127 L176A2026 L17ZA2060 L182A2094 L185A2128 L176A2027 L17ZA2061 L182A2095 L185A2129 L176A2028 L181A2062 L182A2096 L185A2130 L176A2029 L181A2063 L182A2097 L185A2131 L176A2030 L181A2064 L182A2098 L185A2132 L177A2031 L181A2065 L182A2099 L185A2133 L177A2032 L181A2066 L182A2100 L185A2134 L177A2033 L181A2067 L183A2101 L185A2135 L177A2034 L181A2068 L183A2102 L185A2136 L177A2035 L181A2069 L183A2103 L185A2137 L177A2036 L181A2070 L183A2104 L177A2037 L181A2071 L183A2105 L177A2038 L181A2072 L183A2106
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
β οΈ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Qiagen Sciences LLC
- Reason for Recall:
- An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.
Product Codes/Lot Numbers:
L166A1801 L169A1835 L16XA1869 L171A1903 L173A1937 L174A1971 L166A1802 L169A1836 L16XA1870 L171A1904 L173A1938 L174A1972 L166A1803 L169A1837 L16YA1871 L171A1905 L173A1939 L174A1973 L166A1804 L169A1838 L16YA1872 L171A1906 L173A1940 L174A1974 L166A1805 L169A1839 L16YA1873 L171A1907 L173A1941 L174A1975 L166A1806 L169A1840 L16YA1874 L171A1908 L173A1942 L174A1976 L166A1807 L169A1841 L16YA1875 L171A1909 L173A1943 L174A1977 L166A1808 L169A1842 L16YA1876 L171A1910 L173A1944 L174A1978 L166A1809 L169A1843 L16YA1877 L172A1911 L173A1945 L174A1979 L166A1810 L169A1844 L16YA1878 L172A1912 L173A1946 L174A1980 L167A1811 L169A1845 L16YA1879 L172A1913 L173A1947 L174A1981 L167A1812 L169A1846 L16YA1880 L172A1914 L173A1948 L174A1982 L167A1813 L169A1847 L16YA1881 L172A1915 L173A1949 L174A1983 L167A1814 L169A1848 L16YA1882 L172A1916 L173A1950 L174A1984 L167A1815 L169A1849 L16YA1883 L172A1917 L173A1951 L174A1985 L167A1816 L169A1850 L16YA1884 L172A1918 L173A1952 L174A1986 L167A1817 L16XA1851 L16YA1885 L172A1919 L173A1953 L174A1987 L167A1818 L16XA1852 L16YA1886 L172A1920 L173A1954 L174A1988 L167A1819 L16XA1853 L16YA1887 L172A1921 L173A1955 L174A1989 L167A1820 L16XA1854 L16YA1888 L172A1922 L173A1956 L174A1990 L168A1821 L16XA1855 L16YA1889 L172A1923 L173A1957 L175A1991 L168A1822 L16XA1856 L16YA1890 L172A1924 L173A1958 L175A1992 L168A1823 L16XA1857 L16ZA1891 L172A1925 L173A1959 L175A1993 L168A1824 L16XA1858 L16ZA1892 L172A1926 L173A1960 L175A1994 L168A1825 L16XA1859 L16ZA1893 L172A1927 L174A1961 L175A1995 L168A1826 L16XA1860 L16ZA1894 L172A1928 L174A1962 L175A1996 L168A1827 L16XA1861 L16ZA1895 L172A1929 L174A1963 L175A1997 L168A1828 L16XA1862 L16ZA1896 L172A1930 L174A1964 L175A1998 L168A1829 L16XA1863 L16ZA1897 L173A1931 L174A1965 L175A1999 L168A1830 L16XA1864 L16ZA1898 L173A1932 L174A1966 L175A2000 L169A1831 L16XA1865 L16ZA1899 L173A1933 L174A1967 L175A2001 L169A1832 L16XA1866 L16ZA1900 L173A1934 L174A1968 L175A2002 L169A1833 L16XA1867 L171A1901 L173A1935 L174A1969 L175A2003 L169A1834 L16XA1868 L171A1902 L173A1936 L174A1970 L175A2004 L175A2005 L177A2039 L181A2073 L183A2107 L175A2006 L177A2040 L181A2074 L183A2108 L175A2007 L178A2041 L181A2075 L183A2109 L175A2008 L178A2042 L181A2076 L183A2110 L175A2009 L178A2043 L181A2077 L183A2111 L175A2010 L178A2044 L181A2078 L183A2112 L175A2011 L178A2045 L181A2079 L183A2113 L175A2012 L178A2046 L181A2080 L183A2114 L175A2013 L178A2047 L182A2081 L183A2115 L175A2014 L178A2048 L182A2082 L183A2116 L175A2015 L178A2049 L182A2083 L183A2117 L175A2016 L178A2050 L182A2084 L184A2118 L175A2017 L17ZA2051 L182A2085 L184A2119 L175A2018 L17ZA2052 L182A2086 L184A2120 L175A2019 L17ZA2053 L182A2087 L184A2121 L175A2020 L17ZA2054 L182A2088 L184A2122 L176A2021 L17ZA2055 L182A2089 L184A2123 L176A2022 L17ZA2056 L182A2090 L184A2124 L176A2023 L17ZA2057 L182A2091 L184A2125 L176A2024 L17ZA2058 L182A2092 L184A2126 L176A2025 L17ZA2059 L182A2093 L184A2127 L176A2026 L17ZA2060 L182A2094 L185A2128 L176A2027 L17ZA2061 L182A2095 L185A2129 L176A2028 L181A2062 L182A2096 L185A2130 L176A2029 L181A2063 L182A2097 L185A2131 L176A2030 L181A2064 L182A2098 L185A2132 L177A2031 L181A2065 L182A2099 L185A2133 L177A2032 L181A2066 L182A2100 L185A2134 L177A2033 L181A2067 L183A2101 L185A2135 L177A2034 L181A2068 L183A2102 L185A2136 L177A2035 L181A2069 L183A2103 L185A2137 L177A2036 L181A2070 L183A2104 L177A2037 L181A2071 L183A2105 L177A2038 L181A2072 L183A2106
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0383-2019
Related Recalls
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Qiagen Sciences
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Heater shaker module does not perform heating if the temperature is set below 40ΒΏC for static incubation steps when running IVD protocol QIAampΒΏ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost