FDA News

FDA issues class 1 recall of filter tips for assays

The FDA has issued a class 1 recall — the most serious kind of recall — of Qiagen’s pipetting system filter tips. The recall affects 1,269,760 tips in 1,240 kits that are used to monitor antiviral treatment in patients with cytomegalovirus or to evaluate patients for myeloproliferative neoplasms.

The filter tips, which can be used with two FDA-approved or cleared assays (QIAGEN artus CMV QS-RGQ-MDx and ipsogen JAK2 RGQ PCR), may be defective due a manufacturing malfunction, which resulted in internal abrasions from a bent manufacturing pin, according to an FDA MedWatch report. The filter tips may potentially leak, which can lead to inaccurate or delayed results including false negatives, false positives or incorrect quantification.

The affected tips were manufactured between Sept. 7 and Sept. 18, 2018 and were distributed between Feb. 11 and March 9, 2019. Since then, customers have reported liquid in the tip guard, splashes onto the instrument, failed test signals, dripping or leaking tests, incorrect test results and empty wells from the defective tips. The company has received three complaints, although there have been no reported deaths or injuries.

Incorrect results, specifically for patients with undetected conditions, may result in severe adverse health consequences including death, according to the report.

The company distributed a correction letter to customers on June 5, 2019 alerting them to stop using the identified lots and to dispose of them. Customers were also informed to review all test results conducted by this system.

The FDA has issued a class 1 recall — the most serious kind of recall — of Qiagen’s pipetting system filter tips. The recall affects 1,269,760 tips in 1,240 kits that are used to monitor antiviral treatment in patients with cytomegalovirus or to evaluate patients for myeloproliferative neoplasms.

The filter tips, which can be used with two FDA-approved or cleared assays (QIAGEN artus CMV QS-RGQ-MDx and ipsogen JAK2 RGQ PCR), may be defective due a manufacturing malfunction, which resulted in internal abrasions from a bent manufacturing pin, according to an FDA MedWatch report. The filter tips may potentially leak, which can lead to inaccurate or delayed results including false negatives, false positives or incorrect quantification.

The affected tips were manufactured between Sept. 7 and Sept. 18, 2018 and were distributed between Feb. 11 and March 9, 2019. Since then, customers have reported liquid in the tip guard, splashes onto the instrument, failed test signals, dripping or leaking tests, incorrect test results and empty wells from the defective tips. The company has received three complaints, although there have been no reported deaths or injuries.

Incorrect results, specifically for patients with undetected conditions, may result in severe adverse health consequences including death, according to the report.

The company distributed a correction letter to customers on June 5, 2019 alerting them to stop using the identified lots and to dispose of them. Customers were also informed to review all test results conducted by this system.