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The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.