The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- 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 pipetting system filter tips, used exclusively with the QIAsymphony SP/AS instruments, can be used for clinical assay workflows or with in vitro diagnostic tests. The two FDA approved/cleared assays for use with the QIAGEN filter-tips are the QIAGEN artus CMV QS-RGQ MDx (for quantifying cytomegalovirus (CMV) in blood) to aid in monitoring antiviral treatment for CMV, and the QIAGEN ipsogen JAK2 RGQ PCR to aid in the evaluation of patients for myeloproliferative neoplasms. The filter-tips with the QIAsymphony instruments can also be used for laboratory developed tests (LDTs) as part of other clinical workflows, including genetic testing, oncology testing, or for research applications. The devices are used widely, including by commercial laboratories, hospitals, and genetics laboratories.
Reason for Recall
Due to a manufacturing malfunction resulting in defective filter-tips having internal abrasions from a bent manufacturing pin, the affected QIAGEN filter-tips have the potential to leak, which may result in delayed or inaccurate results, including false positive results, false negative results, or incorrect quantification. 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.
Who May be Affected
- Laboratory personnel who used QIAsymphony SP/AS instruments with the affected tips from February 11, 2019 to June 5, 2019.
- Patients who had specimens tested from February 11, 2019 to June 5, 2019 where the QIAsymphony SP/AS instruments with the affected tips were used during the testing process.
What to Do
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.
Customers with questions about this recall may contact QIAGEN Sciences by phone at 1-800-362-7737 or email at TechService-NA@qiagen.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.