Reported Nov 14, 2018 · Terminated

EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform…

Qiagen Sciences LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415

Is this the product you have?

  • EZ1 Advanced XL
  • Model Number9001492
  • GTIN04053228010760
  • Product UsageThe 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
Lot codes and dates
  • 337 of 337 codes

    • 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
Amount recalled
298

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 5, 2020 · Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.