FUJIFILM , FSCA2023-001, Oil for Embryo Culture

FUJIFILM Irvine Scientific has received reports from a small number of customers concerning the performance of Oil Lots 0000011351, 0000011367, 0000015999, 0000016001. 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.
While the lots listed above met all final product release specifications as reported on the Certificate of Analysis (CofA) before distribution, in response to the complaints, FUJIFILM Irvine Scientific conducted an extensive investigation and was able to detect oil toxicity for Lots 0000011351, 0000015999, and 0000016001. No toxicity was detected for the Lot 0000011367. However, all of these lots were derived from the same lot of Raw Material. Potential deficiencies in the affected lots of Oil for Embryo Culture may result in impairment of embryo development and result in poor blastocyst development or non-transferable blastocyst, resulting in the inability to perform the procedure.
As a result of this finding, all finished product Lots sharing the same Raw Material, which include Oil for Embryo Culture Lots 0000011351,0000011367, 0000015999, 0000016001, will be recalled in an abundance of caution.
To the Company’s knowledge, we have no reports of any known patient death or serious injury associated with the affected lots, however, it is important that these devices are not used. No other Oil Lots are affected by this Field Safety Notice.
The product is not intended to come in contact with the patient and there is no evidence of any risk to health to the potential recipient of the embryo. Nevertheless, potential deficiencies in these lots of Oil for Embryo Culture may result in impairment of embryo development and result in poor blastocyst development or non-transferable blastocyst, resulting in the inability to perform the procedure.