Fujifilm Irvine Scientific, Inc.: Due to a component in kit being labeled with the incorrect Expiration Date

Agency Publication Date: November 17, 2021

Affected Products

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 Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocyte

Catalog number: 90133-DSOC Kit- Vitrification Freeze kit: Which contained VS Vitrification solution, Lot/Unit numbers: 90132210403; UDI # 00893727002811; 9 x1 mL Vitrification Solution, VS, Catalog #0132 and 9x1mL. Equilibration Solution, ES Catalog 90131

Catalog number: 90133-SO Vitrification Freeze kit Lot/Unit numbers: 90132210403; UDI # 00893727002811 Product code MLQ

Lot Numbers:

MLQ

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88720

Status: Active

Manufacturer: Fujifilm Irvine Scientific, Inc.

Manufactured In: United States

Units Affected: 2 products (677 units or kits of 90133-DSOC210605 (9 x 1ml per kit); 595 kits in U.S. and 82 kits OUS; 3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS)

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Sources: FDA iRES · Raw API Response

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