Recall Z-1314-2023 ยท MQL Media, Reproductive
Fujifilm Irvine Scientific, Inc.
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
| Date | Apr 1, 2023 (initiated Jan 16, 2023) |
| Status | Open, Classified |
| Reason | Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. |
| Root cause | Nonconforming Material/Component |
| Action | On 01/16/2023, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that, the firm has received complaints of 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 testing, and reported low sperm motility. Customers are instructed to: 1. Immediately stop using the product; 2. Quarantine any remaining product in inventory; 3. Return or destroy the product; 4. Complete and return the e |
| Quantity | 15,131 bottles |
| Distribution | U.S.: AZ, AR, CA, CT, DC, FL, HI, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WI and WV. O.U.S.: India, Israel, Japan, Malaysia, Mexico, South Korea, South Africa, Thailand, Vietnam, Brazil, Bosnia, Argentina, Netherlands, and United Kingd |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011938 | OIL FOR EMBRYO CULTURE Irvine Scientific Sales Co., Inc., Jul 18, 2001 |