Class I Recall of QIAGEN Filter Tips

PUBLISHED: Aug 5, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has announced a Class I recall of QIAGEN filter tips for use with the QIAsymphony SP/AS instruments due to potential to leak, which may result in delayed or inaccurate results. Customers have reported splashes on the QIAsymphony instrument, liquid in the tip guard, dripping/leaking tips, failed test signals, empty wells indicative of volume loss, and incorrect test results with use of the defective tips.

Severe adverse health consequences, including death, could potentially occur if incorrect results are not detected. The risks are dependent on the specific test being run and how important the test result is for clinical diagnosis. For example, false positive results using the JAK2 assay could provide support for the diagnosis of a myeloproliferative neoplasm, potentially culminating in stem cell transplantation, which has a risk of long-term complications including increased mortality and secondary malignancy.

The company received three complaints from U.S. customers. There were no injuries or deaths reported.

Recalled Product

  • Filter Tips, 1500 μl (for use with the QIAGEN QIAsymphony SP/AS Instruments)
  • Lot numbers distributed in U.S.: 0605020019, 0605020020
  • Model number: REF 997024
  • Manufacturing Dates: September 7, 2018 to September 18, 2018
  • Distribution Dates: February 11, 2019 to March 9, 2019
  • Devices Recalled in the U.S.: 1,269,760 tips in 1,240 kits
  • Date Recall Initiated: June 5, 2019

QIAGEN issued a correction letter on June 5, 2019, to its U.S. laboratory customers, with the following instructions:

  • Stop using identified lots of affected Filter-Tips and to dispose of the product in accordance with national and local safety and environmental regulations.
  • Be aware that affected tips may cause or have caused delayed or incorrect results within workflows.
  • Review the Device Correction Notice with your laboratory/medical director.
  • Review results obtained from assays where the QIAsymphony SP/AS instruments were used in any part of the testing process and if affected tips were used.
  • Forward this information to all individuals and departments who are using the above listed kit within your organization. If you are not the end user, please forward this notice to the product end user.

Complete the Acknowledgement of Receipt form attached to the letter notifying QIAGEN that you are aware of this recall and the actions to be taken.

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