Qiagen Rotor Gene11/10/2020
The recognition, which Qiagen started on January.US Meals and Medication Administration website on Thursday.
It is certainly a class II recognition, meaning that the underlying problem could cause serious injury or short-term sickness in sufferers. Qiagen issued an immediate medical device correction via email to clients on January. Qiagen Rotor Gene Upgrade To TheLIMS. The organization also recommended customers to upgrade to the most recent edition of the RGQ software program (2.3.5), which became available in earlier February. Laboratory personnel and clinicians are recommended to consider a sufferers previous check results, some other diagnostic tests, anamnesis, and present clinical situation when interpreting results from this software program, the call to mind notice expresses. If the outcomes do not match up the sufferers clinical display, or incongruences are usually found with earlier and concomitant lab tests or the outcomes are otherwise unpredicted, the individual example should become retested making use of an alternative test method or a guide laboratory. The thought does apply to a quantity of variations of the RGQ platform and can affect several various Qiagen IVD kits that typically run on the system, including tests for BK trojan, cytomegalovirus, Epstein-Barr pathogen, hepatitis C and Chemical viruses, HIV-1, Varicella-Zoster computer virus, JCV, Mycobacterium tuberculosis, parvovirus W19, and SARS disease. In an e-mail, Qiagen spokesperson Thomas Theuringer said that Qiagen released the notification after being made aware of the issue by a solitary customer in Asia, and that no additional customers possess since documented the problem. The upgrade can become very easily downloaded and installed by any client. The Rotor-Gene Q platform has also happen to be determined by thé FDA as á suitable instrument for performing the US Centers for Disease Controls Emergency Make use of Authorized check for SARS-CóV-2, the book coronavirus leading to the global COVID-19 outbreak. ![]() ![]()
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