QC Services Investigation: PMM-QC-1480
QC
This investigation looked at all peer group data for the same assay reagent and Optitrol Blue lot and any other Optitrol Blue lot with data reported to EDCNet using the reagent lots in question (45574FN00 and 47571FN00), to establish whether these reagent lots were the source of any variation observed.
QC Services Investigation: PMM-QC-1583
QC
NRL was contacted by EDCNet participants regarding negative S/Co values observed for Optitrol HIVp24 lot DM22200 when testing with the DiaSorin LIAISON XL MUREX HIV Ab/Ag Assay, on reagent lot 139054. NRL investigated all data reported by the peer group. All Optitrol HIVp24 and reagent lots in use were reviewed for the DiaSorin LIAISON XL MUREX HIV assay along with data for all other assays where Optitrol HIVp24 is recommended for use, to establish if the negative S/Co values were observed for any other participant, Optitrol HIVp24 or reagent lot.
QC Services Investigation: PMM-QC-1593
QC
This investigation reviewed data reported to EDCNet for Optitrol Blue lots DM22009 and DM22121 reported for the Abbott Alinity s Anti-HTLV I/II assay and the Abbott Alinity i, Abbott Architect and DiaSorin Liaison platforms to establish if this variation was observed across any other platform.
QC Services Investigation: PMM-QC-1661
QC
This report will review data reported to EDCNet for reagent lot numbers affected by the notice to establish if trends or variation are observed across the peer group.
QC Services Investigation: PMM-QC-1784
QC
Data were reviewed for Optitrol ToRCH M DM22191 for data reported to EDCNet for all other assays and platforms Optitrol ToRCH M is validated for with no similar trend or pattern observed.
QC Services Investigation: PMM-QC-1878
QC
NRL observed a shift up in S/Co values for Optitrol HEPR-2 DM24038 when tested with the Abbott Alinity i HAV Ab IgG assay. NRL investigated the performance of Optitrol HEPR-2 DM24038 and other related production lots, DM23002 and DM23080, as well as the performance of Optitrol HEPR-2 DM24038 when used with the Abbott and other assays and platforms the EQC had been designed for establish if this variation was observed across any other platforms and or Optitrol lots for root cause investigation.
QC Services Investigation: PMM-QC-2025
QC
An investigation regarding a shift up in data observed for Optitrol Blue lot DM23117 when testing with the Abbott Alinity i rHTLV-I/II assay for reagent lot 60107BE00.  The investigation looked at all peer group data reported for this assay and related production lots of Optitrol Blue, in addition other Alinity i assay and both the Alinity s and ARCHITECT HTLV assays where Optitrol Blue were reported were also reviewed to establish whether reagent lot variation was the source of the variation observed.  
QC Services Investigation: PMM-QC-2434
QC
NRL was contacted by an Optitrol QConnect Distributor regarding an observed progressive decrease in S/Co value when testing Optitrol Blue DM23117 on the Abbott Alinity i HBsAg Qualitative II assay and  Abbott ARCHITECT HBsAg Qualitative II assay. All data available reported to EDCNet for HBsAg assays testing with Optitrol Blue DM23117 were reviewed.
QC Services Investigation: PMM-QC-2532
QC
During routine review of data reported to EDCNet it was observed that Optitrol Blue DM24249 data were reported below the assay cut off when testing on the DiaSorin LIAISON XL MUREX HCV Ab assay. All data reported to EDCNet for Optitrol Blue DM24249 on both the DiaSorin LIAISON XL MUREX HCV Ab and other assays where Optitrol Blue is the recommended Optitrol QC product for use were reviewed to establish whether a negative shift was observed for any other peer group and identify a possible root cause.
QC Services Investigation: PMM-QC-2585
QC
During routine review of data submitted to EDCNet it was observed that Optitrol Yellow DM24064 data were reported below the NRL QConnect Range when testing on the Abbott Alinity s HIV Ag/Ab Combo assay for reagent lots 71610BE00 and 73319BE00. NRL investigated all peer group for data submitted to EDCNet for Optitrol Yellow and Abbott Kit positive controls for the Alinity s HIV Ag/Ab Combo assay (Alinity s HIV assay).
QC Services Investigation: PMM-QC-2684
QC
In early 2022 Abbott released a new anti-HCV assay for the Alinity s platform (Abbott Alinity s Anti-HCV II) and it was observed that the previously recommended Optitrol product - Optitrol Blue, designed and manufactured for the Abbott ARCHITECT, Alinity i and Alinity s platforms - was not performing as expected on the new Alinity s Anti-HCV II assay. In response a new product - Optitrol Yellow - was designed and manufactured by DiaMex, in partnership with NRL, and specifically recommended for use on the Abbott Alinity s platform. This report provides a summary of peer group performance for all Alinity s since January 2024 for Optitrol Yellow.
QC Services Investigation: PMM-QC-689
QC
NRL was contacted by Abbott Laboratories, Australia, regarding Participant 128 having reported that there was evidence to suggest there was greater variation observed for HEPR:DM17216 since the introduction of the ARCHITECT anti-HBs version 3.
QC Services Investigation: PMM-QC-706
QC
During a routine review of EDCNet, it was observed for the Abbott ARCHITECT HIV Ag/Ab Combo assay testing with QConnect Blue DM18210, Participant 39 data was above the upper limit and not in line with peer group data.
QC Services Investigation: PMM-QC-713
QC
Participant 57 completed an evaluation of QConnect QC products and EDCNet. This report is a summary of the testing data submitted into EDCNet from 01 January to 30 September 2019.
QC Services Investigation: PMM-QC-794
QC
NRL was contacted by participants 129 and 145 regarding the occurrence of random drops in data results, some falling below the lower QConnect range, for QConnect HIV p24, DM19142 on the Abbott ARCHITECT HIV Ab/Ag Combo assay.
QC Services Investigation: PMM-QC-860
QC
NRL was contacted by Participant 8, to investigate a downward trend observed for QConnect HEPR lot DM20291 when testing with the Abbott Alinity i Anti-HBs and Anti-HAV IgG assays.
QC Services Investigation: PMM-QC-885
QC
During daily out of range (OOR) and monthly data reviews of EDCNet, a number of ‘random drops’ were noted for the Optitrol HIV Screening QC testing on the Grifols PANTHER Ultrio Elite HBV/HCV/HIV assay.
QC Services Investigation: PMM-QC-981
QC
During daily review of out of range (OOR) data submitted to EDCNet, a number of data were reported by multiple participants within the peer group as S/Co <1.00 for Optitrol Red QC lots DM20156 and DM21157 when testing with the Bio-Rad MONOLISA HBsAg ULTRA assay reagent lot 1K0709.
QC Services Investigation: PMM-QC-982
QC
During scheduled monitoring review of QC data submitted to EDCNet for Optitrol ToRCH M QC testing with the DiaSorin LIAISON HSV-1/2 IgM assay, it was observed that all data entered under QC lot DM20144, were entered at the upper limit of the assay, Index Value (IV) 3.50.