The US Food and Drug Administration (FDA) issued a warning letter on Tuesday stating that QIAGEN (headquartered in Maryland) has inadequate blood tests for the diagnosis of tuberculosis (TB) and that there are too many complaints about false positives.
FDA inspection found that QuIFERON-TB Gold (QFT) test equipment approved by QIAGEN in 2005, " adulteration..., the company's current methods of manufacturing, packaging, storage, or installation, facilities, and control and quality system regulations are good. Production specification requirements are not met."
The FDA stated in a warning letter on May 16 that multiple corrective and preventive measures (CAPA) were disclosed for the trial device due to consecutive complaints of false positive rates.
QIAGEN's corrective actions were also referred to as “ineffective†because contract manufacturers were unable to meet the new norm and lacked endotoxin plus studies to determine how much endotoxin content in the negative control tube would lead to false negative results. In addition, the FDA noted that due to the implementation of changes in endotoxin specifications, the manufacture of tuberculosis antigen tubes and negative control tubes lacks process validation and release.
In addition, endotoxin is not included in the quality requirements document that QIAGEN blood collection tube contract manufacturers must follow.
Another CAPA was disclosed as one of the batches was found to be contaminated with endotoxin in two batches of blood collection tubes. “It may lead to potential false negative results,†the FDA said, stating that this CAPA was not effective, although only a portion of the two batches were released and some of them failed the batch release test. â€
The agency also took the facts to illustrate the issue, and the verification documents filed by QIAGEN did not directly address endotoxin levels, nor did it provide evidence that its current process was validated. â€
Violation report
The FDA will list the QFT device as a counterfeit product, and if QIAGEN receives the warning letter or is aware of the problem by any means within 30 days, it will not be able to submit the corresponding report. The FDA requires QIAGEN to make reasonable comments in its report that its company's equipment has failed in the market and that if the failure occurs again, such equipment or similar devices sold in the market may cause or cause death or serious hurt. â€
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Specifically, the US FDA refers to two devices that were recalled in Japan due to a malfunction.
Qiagen spokesperson Thomas Theuringer told Focus that the QFT test was no problem and did not receive a request to stop selling the product... We took these issues seriously and took appropriate action to correct the process and ensure compliance with the FDA. . These include the ongoing transfer of QFT manufacturing to Qiagen's headquarters in Germantown, Maryland, and improvements in the transition to fourth-generation versions of the product. â€
He also said that Theranos is in dire straits because of its mistakes in FDA-approved blood test equipment. Comparing the two companies is like making an apple and pear comparison.
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