Filter Tips for use with the QIAsymphony SP/AS Instruments by QIAGEN: Class I Recall - Due to Potential to Leak, Which May Result in Delayed or Inaccurate Results AUDIENCE: Laboratory, Health Professional, Risk Manager ISSUE: 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. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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