Test, Equipment, Automated Bloodborne Pathogen

Reports per year

Source: FDA adverse event reports by year received, 2014–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2013-07-02TerminatedDevice Design

  ORTHO Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific pipetting protocols and ORTHO Assay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing.

  There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

• Open, ClassifiedUnder Investigation by firm

  Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

  Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

• Open, ClassifiedSoftware design

  Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

  A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.