FUJIFILM Irvine Scientific Inc, FSN-FSCA2023-002, Oil for Embryo Culture

Per the delivery note on your order, your facility should have received lot 0000011349; however, your facility received lot 0000015999. FUJIFILM Irvine Scientific Inc. recently performed a voluntary recall of Oil for Embryo Culture, Catalog #9305, which included lot 0000015999. Following this recall, Lot 0000015999 was placed in quarantine and should not have been shipped to you. You should immediately discontinue use of Lot 0000015999 and take the further actions described below.

FUJIFILM Irvine Scientific received reports from a small number of customers concerning the performance of four lots of Oil for Embryo Culture, Catalog #9305. One of these four lots was Lot 0000015999. The complaints reported reduced blastocyst development, including complete degradation in some cases, during culture of human embryos. Additionally, some clinics performed Human Sperm Survival Assay (HSSA), as part of incoming, confirmatory Quality Control (QC) testing and reported low sperm motility.