Device Use

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.