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Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated.
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
Motor Coach Industries (MCI) is recalling certain 2019-2021 D45CRTLE, J3500, and J4500 coaches, equipped with a rear-mounted bike rack. The vehicle's rear lighting may be obstructed when bikes are installed on the bike rack. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."