Fisher Diagnostics Infinity Ammonia Standard Set

Fisher Diagnostics is initiating field safety corrective action for the product Infinity™ Ammonia Standard Set because we have received complaints from customers reporting approximately 6% to 15% low calibration bias after switching ammonia standard lots and attributed the bias to the calibrators. This observed issue applies to customers who purchased the product listed in Table 1. This issue may lead to prognostic misclassification for mortality thresholds, a delay in the initiation of time-sensitive treatment measures, and/or errors in clinical treatment decisions; this may cause development of serious patient harm.