Access Hstni

FA-000604, which was distributed in August 2021, notified customers of possible intra-assay carryover. The letter communicated that clinically significant carryover into a reagent pack (into-pack) can occur if an Access Hstni test is performed after a sample with a CTNI concentration >270,000 pg/ml (ng/l) and uses the same reagent pipettor. A subsequent investigation has determined that sample-to-sample carryover may also occur under certain conditions confirming that intraassay carryover encompasses into-pack and sample-to-sample carryover. Through these subsequent studies, BEC determined that clinically significant sample-to-sample carryover can occur in Hstni samples that are tested after a sample with a CTNI concentration >55,000 pg/ml (ng/l).

Recall start date: Feb 9, 2022