Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
FDA Recall Z-1314-2023 · Posted 2023-04-01
Advertisement
Recalling FirmFujifilm Irvine Scientific, Inc.
Recall StatusOpen, Classified
Product CodeMQL
Date Initiated2023-01-16
Product Quantity15,131 bottles
Reason for Recall
Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
Firm 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 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]
Root Cause
Nonconforming Material/Component
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement