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Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.