EZ1 Advanced XL
Medical device recall Z-0383-2019. Published in FDA’s Enforcement Report on Nov 14, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 14, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 21 states named
- 298 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
298, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
L166A1801 L169A1835 L16XA1869 L171A1903 L173A1937 L174A1971 L166A1802 L169A1836 L16XA1870 L171A1904 L173A1938 L174A1972 L166A1803 L169A1837 L16YA1871 L171A1905 L173A1939 L174A1973 L166A1804 L169A1838 L16YA1872 L171A1906 L173A1940 L174A1974…
Every code shown here, 2,000 characters
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…
FDA’s list runs to 3,369 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, GA, IA, ID, IL, MA, MD, MI, MN, NE, NJ, NY, NV, OH, PA, PR, SD, VA, and WA. The products were distributed to the following foreign countries: Alger, Argentina, Australia, Austria, Canada, China, Dubai, Egypt, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Korea, Latvia, Mexico, Morocco, Norway, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, UK.
The states and territories these words name
21 states and territories.
Every one of them
- Arizona
- California
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Pennsylvania
- Puerto Rico
- South Dakota
- Virginia
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 23, 2018.
- FDA classified it on Nov 3, 2018.
- FDA’s Enforcement Report published it on Nov 14, 2018.
- FDA terminated it on Jun 5, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Qiagen Sciences LLC, of Germantown, MD.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,369 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.