The Recall Desk

FDA (Devices) recall action 88720

Fujifilm Irvine Scientific, Inc. recalled 2 products on 2021-11-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-11-24
Critical
0
Units
—

Why these products were recalled

Due to a component in kit being labeled with the incorrect Expiration Date

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2021-11-24

    Reproductive Medical Device Recalled for Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze, a medical device used in assisted reproductive procedures, due to kit components being labeled with incorrect expiration dates.

    Product
    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 kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Distribution
    35 states
  • ModerateFDA (Devices)··2021-11-24

    Vitrification Freeze Kit Recalled Due to Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze due to incorrect expiration date labeling on a component. The incorrect label could lead to use of degraded solutions in assisted reproductive procedures.

    Product
    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 kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Distribution
    35 states