Regulatory Focus™ > News Articles > Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device

Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device

Posted 24 May 2016 | By Zachary Brennan 

Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device

The US Food and Drug Administration (FDA) on Tuesday released a warning lettter for Maryland-based Qiagen over deficiencies with its blood test used for diagnosing tuberculosis (TB), noting multiple complaints for high false positive rates.

FDA’s inspection found that Qiagen’s QuantiFERON-TB Gold (QFT) test device, first approved in 2005, “is adulterated … in that the methods used in or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation.”

Multiple corrective and preventive actions (CAPAs) had been open due to repeated complaints for high false positive rates, FDA noted in the warning letter issued on 16 May. 

Qiagen’s corrective action was also cited as “not effective” because the contract manufacturer could not meet the required new specification and “there were no endotoxin spiking studies to determine what amount of endotoxin contamination of the Nil tube could cause a false negative result. Furthermore since the endotoxin specification change was implemented, the TB Antigen and Nil tubes were manufactured without process validation and released,” FDA said.

In addition, the documented quality requirements that must be met by Qiagen’s contract manufacturer of QuantiFERON blood collection tubes “do not include endotoxin.”

Another CAPA, opened due to endotoxin contamination found in two lots of one of the blood collection tubes, “could lead to potentially false negative results,” FDA said, noting that this CAPA “was not effective as portions from both lots were released despite multiple failures being obtained during lot release testing.”

The agency also took issue with the fact that the validation documents included in Qiagen’s response “do not directly address endotoxin levels and do not provide evidence that your current process has been appropriately validated.”

Reporting Violations

FDA also found the QFT device to be misbranded as Qiagen failed “to submit a report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.”

Specifically, FDA points to two Japanese recalls after malfunctions with the devices.

Thomas Theuringer, spokesman for Qiagen, told Focus that there are "no performance issues with the QuantiFERON-TB Gold (QFT) test and there is no request to discontinue selling the product ... We take these matters seriously and have already taken appropriate actions to correct the procedures and ensure FDA compliance. This includes making improvements during the ongoing transfer of QFT manufacturing and the transition to the fourth-generation version to the Qiagen site in Germantown [Maryland]."

He also said the comparison to Theranos, which has come under fire for its faulty blood testing device that has not been approved by FDA yet, as an "apples to pears" comparison.

Editor's note: This article was updated on 5/25/16 with Qiagen comments and more background on Theranos.

Warning Letter


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