2025 | ||
|---|---|---|
| Notification Title | Notification Date | Information Provided |
| CMV assay disruption extension notice | September 2025 | We have now received an updated communication from Werfen extending the expected duration of the supply disruption; the reagent shortage is now anticipated to continue through the end of November 2025 |
| In-house confirmatory HTLV I/II Immunoblot testing | July 2025 | ViroMed Laboratories no longer performs in-house confirmatory HTLV I/II Immunoblot testing for cadaveric samples. |
| Immucor Capture-CMV® assay supply disruption | July 2025 | ViroMed Laboratories was recently notified by Werfen, manufacturer of the Immucor Capture-CMV® assay, of a supply disruption to one of the assay’s key components that is preventing the release of new reagent lots. This disruption is expected to last until at least the end of September 2025. |
| Anti-HCV II Assay Transition | June 2025 | Transition to the Abbott Alinity s Anti-HCV II assay for screening all living and cadaveric donors |
| Syphilis Screening Disruption | June 2025 | Due to an unforeseen disruption to the supply of Trinity BioTech CAPTIA Syphilis (T. pallidum)-G kits, effective immediately, ViroMed is suspending donor syphilis screening using this assay |
| Cadaveric Specimen Requirements | May 2025 | Cadaveric specimens must be collected within 24 hours of an individual's time of death |
| Performing enhanced screening | February 2025 | Performing enhanced screening to detect weak D antigen |
2024 | ||
|---|---|---|
| Notification Title | Notification Date | Information Provided |
| Discontinuation of Zika Virus NAT testing | December 2024 | ViroMed Laboratories will discontinue offering Zika Virus NAT testing |
| Moving Manual CMV to the NEO Iris | September 2024 | Testing Platform change to CMV Total Ab |
| 1129850 PK7300 Discontinuation | September 2024 | Testing platform changes to ABO Group/Rho(D) Type and Syphilis (T. pallidum) |
2023 | ||
|---|---|---|
| Notification Title | Notification Date | Information Provided |
| Procleix Panther Phase 1 | March 2023 | Phasing out Cobas 6800, new Procleix Panther |
| Procleix Panther Phase 2 | June 2023 | Discontinuation of Cobas 6800, full testing of Procleix Panther |
| EU – CE-Mark | July 2023 | Discontinuation of Testing |
| Geenius Reagents | November 2023 | Kit Backorder until at least January 2024 |