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Fda eua approved qualitative analysis of sars-cov-2 using the applied biosystems taqpath covid 19 combo kit at genetox worldwide llc d/b/a trugenx, we have been experiencing significant issues with thermo fisher scientific ("thermo") and its products with respect to covid-19 testing, with thermo fisher scientific applied biosystems 7500 fast dx real-time pcr instrument in particular.Unfortunately, due to faulty and defective products (all of which have been purchased from thermo), we have no choice but to suspend all covid-19 testing for our clients and their patients, as per the following: in late (b)(6), we failed about fifteen plates in a matter of two days due to no ms2 in the negative control.In (b)(6), we were having issues with plates failing due to no amplification of ms2 in the negative control.The problem worsened, followed by a lack of ms2 amplification in the samples.After several days of repeatedly failing plates, thermo's senior healthcare sales specialist - (b)(6) genetic sciences division suggested going back to original skus of dw magnet tip combs because another lab was having similar issues when using alternative skus (which thermo shipped due to supply shortage).They shipped two boxes of original sku dw magnet tip combs (lot#: 27009534).Plates then passed for about two weeks.In late-(b)(6), plates started to fail due to no ms2 amplification for the ms2 in the control or the samples.The genetic analysis solutions representative from applied biosystems brought over new/fresh lots of ms2, which we switched over to immediately.On (b)(6) 2020, a thermo field application scientist (fas) came in to review our workflow.In early (b)(6), plates began to fail again.However, this time, there was no evidence of amplification for the ms2 in the control or the samples.Thermo fass were on site for four days, two nights troubleshooting and overseeing our workflow.However, to no avail, as plates continued to fail.Due to the fact that other labs were having similar issues, the fas suggested using two negative controls and two positive controls on our pcr plates, therefore increasing the chance of the plate passing.We received our new shipment the next day and we started the new reagents.With then-new reagents and two negative controls, plates then started passing.Plates passed with new reagent/alternative control from (b)(6).On (b)(6) 2020, plates started to fail again, this time due to n gene amplification in the negative therefore making qcs fail.We then noticed even if the qcs passed on a plate, the n gene was in the samples as well causing a high number of inconclusives and false positives.On (b)(6) 2020, thermo fas came onsite and did a detail review and performed runs with contamination test plates and mastermix reagent plate.One of the plates was swabs of the lab where we found that two genes showed up on our centrifuge swab.It was cleaned/decontaminated.The other plate contained mastermix (assay lot #2008142 and lot#2008147).The mastermix containing assay lot#2008142 showed two positive genes.Plates continued to fail and/or have high number of positives and inconclusives.We reached out to thermo again.We requested an engineer to assist us on (b)(6) 2020; however, an fas did not arrive until (b)(6) 2021.Since then, thermo has still been unable to rectify the issues at hand to allow us to accurately produce covid-19 testing results in accordance with the appropriate procedures and workflow.Thermo acknowledged that when this problem began in mid-(b)(6) that they were unresponsive to our problems and negligent in their support.Thermo has also acknowledged on phone calls that due to the spike in covid-19 testing in (b)(6) that their supply chain was overwhelmed with request, and that supplies were being depleted by customers that were not even testing for covid-19.Again, trugenx has been forced to suspend all covid-19 testing.Fda safety report id# (b)(4).
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