FDA Device recall Z-0383-2019
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation…
- FDA Device
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation… by Qiagen Sciences, citing 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 occu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0383-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-23 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Qiagen Sciences |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | L166A1801 L169A1835 L16XA1869 L171A1903 L173A1937 L174A1971 L166A1802 L169A1836 L16XA1870 L171A1904 L173A1938 L174A197…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 L16Y |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0383-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.