Santa Ana, CA, United States
Fujifilm Irvine Scientific, Inc. recalls
3 recalls recorded since 2018, most recently on 2 November 2023. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 November 2023
- Reason
- The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).
- Distribution
- US: OK, CA, DC, NC, NV, TX, MI, IN, NY, UT, WI, MN, PA, WV, NJ, IL, LA, WA, OR, FL, IA. OUS: GB, NL, AR, MY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0998-2024
- Sperm separation media are used to separate motile sperm from other constituents of semen.
Ongoing Class II Medical devices
- Recall started
- 16 January 2023
- Reason
- Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1314-2023
- Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Ongoing Class II Medical devices
- Recall started
- 8 September 2021
- Reason
- Due to a component in kit being labeled with the incorrect Expiration Date
- Distribution
- Worldwide Distribution: U.S. (nationwide) to states of: AL, AK, AZ, CA, CT, DE, FL, ID, IL, IN, ND, NC, NV, NY, NJ, NE, OH, OK, OR, PA, SC, SD, MA, MS, MI, MO, MD, MN, TN, TX, UT, VA, VT, WI, WV and OUS (international) to countries of: Brazil, EU, Canada, India, South Korea, and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0249-2022, Z-0248-2022
- Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This
- Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.