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 recalled 3,981 units of its Vit Kit-Freeze vitrification and storage kit used in assisted reproductive procedures. The recall was initiated because a component within the kit was labeled with an incorrect expiration date. The affected kits have catalog number 90133-SO with lot/unit number 90132210403 and UDI number 00893727002811.
The recalled kits were distributed worldwide, including to 34 U.S. states and internationally to Brazil, the European Union, Canada, India, South Korea, and Singapore. Of the total recalled units, 314 kits were distributed in the United States and 3,667 units were distributed internationally. 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: 3981 units of Vitrification Freeze Kit 90133-SO210605; 314 kits in U.S. and 3667 OUS Lot/code info: Catalog number: 90133-SO Vitrification Freeze kit Lot/Unit numbers: 90132210403; UDI # 00893727002811 Product code MLQ
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.