Recall Z-1314-2023
Fujifilm Irvine Scientific, Inc. · initiated January 16, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Codes / lots: UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001
Reason for recall
Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 enclosed MEDICAL DEVICE RETURN RESPONSE FORM; and 5. Email the completed MEDICAL DEVICE RETURN RESPONSE FORM to fisira@fujifilm.com by January 23, 2023. For questions, contact: Customer Service Manager, Medical Business: - Toll free in the US: 1.800.577.6097 - Phone: 1.949.261.7800 x457 - Email: Melissa Gomez, fisitmrequest@fujifilm.com
Details
- Recall number
- Z-1314-2023
- Initiated
- January 16, 2023
- Posted by FDA
- April 1, 2023
- Product code
- MQL – Media, Reproductive
- 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 Kingdom
- Recalling firm
- Fujifilm Irvine Scientific, Inc., Santa Ana, CA