Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
FDA device recall Z-1314-2023 · posted 2023-04-01 · Open, Classified
Recall details
- Recalling firm
- Fujifilm Irvine Scientific, Inc.
- Reason for recall
- Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- MQL
- Quantity affected
- 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, Sou
- Date initiated
- 2023-01-16
- Date posted
- 2023-04-01
- Location
- Santa Ana, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OIL FOR EMBRYO CULTURE (K011938) | Irvine Scientific Sales Co., Inc. | 2001-07-18 |