[119654307]
Re: qiagen's fda jak2 rgq pcr kit ivd. I've been using the ipsogen jak2 rgq pcr kit from qiagen since (b)(6) 2017 utilizing the software that qiagen supplied and installed in concordance with the fda's original approval for the kit. While trying to resolve an ongoing issue with their technical support team, they informed me that i was using the wrong software and that i was officially off label. After investigating this info, i learned that qiagen submitted a 510(k) (k172287) in july 2017 which included the change in software. This was approved for market in january of 2018, 8 months ago. This software is not an upgrade to their previous software, nor is it compatible with the previous software according to their website. Now they are not willing to offer me further technical support until i can get the current approved software. As a result of that response, i have had to suspend testing until a member of qiagen's service team can come onsite and update the software and i can properly validate it. As this was a new assay addition to our lab, i performed my entire validation on the predicate software version over the course of 2018. As a user of this product, i should have been officially notified by qiagen of this change in writing. My name is on the contract and i am the official contact person in their records. My qiagen rep have all begged apologies and cannot explain why i wasn't notified, and they themselves claimed to be unaware of the change. I would like to know that when changes are made to an fda medical device, the mfr is held responsible for notifying their consumer / user. I feel like they need to show the fda how this was carried out to prevent events like this from happening. It doesn't matter how major or minor the change may be. In my case, it was implied that it was major enough that they wouldn't support me on the old software. I have made a formal written complaint through my rep and demanded they be on-site september 4th to provide the software and to compensate with the needed materials to perform the necessary validation. They have complied, but i still have not received a formal notification from qiagen for my records.
Patient Sequence No: 1, Text Type: D, B5