Roche

ROP SIX

Medicare add-on payments

New
0
Continued
0
Lost
1
Roche: technologies on the Medicare add-on payment list
StatusTechnologyMax add-on paymentImplied cost per case
LostEPKINLY (epcoritamab-bysp) and COLUMVI (glofitamab-gxbm)$6,504prior-year maximum$10,006

FDA device recalls, last 36 months

FDA data as of . Source: openFDA.

FDA device recalls, most serious first
ClassProductReasonInitiatedFDA record
Class IIHamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.Software issue that can cause an increase in spontaneous software closures.Jun 10, 2026FDA record
Class IInavify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code:…Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer windowApr 20, 2026FDA record
Class IIProtocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park…Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.Mar 24, 2026FDA record
Class IISequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variantsMar 20, 2026FDA record
Class IIcobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material…Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative…Jan 20, 2026FDA record
Class IIThe Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence…Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.Nov 21, 2025FDA record
Class IIFoundationOne Companion Diagnostic (F1CDx)Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx…Apr 9, 2025FDA record
Class IIcobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteineAbnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)Oct 17, 2024FDA record
Class IICreatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK)…Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.Aug 15, 2024FDA record
Class IIVentana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVDTheir is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.Jun 27, 2024FDA record