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 K
Check against the official notice below — it lists the full affected range.
Fujifilm Irvine Scientific, Inc. is recalling its Vit Kit-Freeze product, which is used in assisted reproductive procedures to vitrify and store human egg cells and early-stage embryos. The recall affects 677 units of the kit (595 in the U.S. and 82 internationally) because one component in the kit was labeled with an incorrect expiration date.
The affected product is catalog number 90133-DSOC210605, which was distributed nationwide in the U.S. and to Brazil, the European Union, Canada, India, South Korea, and Singapore. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a component in kit being labeled with the incorrect Expiration Date
Reason for recall: 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. Quantity: 677 units or kits of 90133-DSOC210605 (9 x 1ml per kit); 595 kits in U.S. and 82 kits OUS Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.