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HVAD Pump (Heartware) – usage clarification (2023)

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Low

FDAOct 31, 2023Nationwide• Heartware, Inc.

4Kscore Test (BioReference) – modeling adjustment (2023)

Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.

Low

FDAOct 31, 2023Nationwide• BioReference Health, LLC

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HVAD Pump (Heartware) – usage clarification (2023)

4Kscore Test (BioReference) – modeling adjustment (2023)

ELISA Parvovirus B19 IgM Test (Zeus) – conjugate modification (2023)

HVAD Pump Implant Kit (Heartware) – usage clarification (2023)

Acrobat-i Positioner (Maquet) – arm locking failure (2023)

HVAD Implant Kit (Heartware) – usage clarification (2023)

HVAD Pump Kit (Heartware) – usage clarification (2023)

HVAD Pump (Heartware) – usage clarification (2023)

Snapshot NIR (Kent Imaging) – touchscreen unresponsive (2023)

DKS Kerrison System (Folsom) – unauthorized distribution (2023)

Small DKS Kerrison System (Folsom) – unauthorized distribution (2023)

Alinity HCV AMP Kit (Abbott) – false positive results (2023)

PHYSICA HPS Tibial Liner (Limacorporate) – labeling error (2023)

RAPIDPoint Cartridge (Siemens) – sodium sensor bias (2023)

Elekta Synergy (Elekta) – arm extension risk (2023)

Precise Digital Accelerator (Elekta) – arm extension risk (2023)

Versa HD Radiation System (Elekta) – arm extension risk (2023)

VITROS ECO2 Slides (Ortho-Clinical) – cart contamination (2023)

AXESSE Radiation System (Elekta) – arm extension risk (2023)

CD11b APC (BD Biosciences) – cell staining quality (2023)