The investigation determined that lower than expected vitros lithium (li) results were obtained from vitros performance verifier quality control fluids and two patient samples processed using vitros li slide lot 3128-0120-2296 on a vitros xt 7600 integrated system.The investigation determined the assignable cause of this event was due to a non-reactive cartridge, where the integrity of the foil wrapper was compromised, exposing the slides to ambient conditions.The lower than expected vitros li results were isolated to a single slide cartridge.The event is consistent with a slide cartridge that has been exposed to ambient conditions.Acceptable vitros li results were obtained from the cartridges in use prior to the affected cartridge and using an alternate slide cartridge (same lot) after the effected slide cartridge was unloaded from the instrument.The customer inspected the cartridge foil wrapper and identified a puncture.The cause of the puncture in the foil wrapper was not determined.(b)(4).
|