Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Recall
- Recall Number
- Z-1314-2023
- Event Number
- 91557
- Firm
- Fujifilm Irvine Scientific, Inc.
- FEI Number
- 2022379
- Product Code
- MQL
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- January 16, 2023
- Posted
- April 1, 2023
- Address
- 2511 Daimler St, Santa Ana, CA, 92705-5533
Description
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
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 [email protected] 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, [email protected]
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
15,131 bottles