Reported Nov 24, 2021 · Ongoing
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes…
Fujifilm Irvine Scientific, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Irvine Scientific, Inc. · 2511 Daimler St · Santa Ana, CA · 92705-5533
Is this the product you have?
- 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 oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos
- Catalog numbers
90133-DCOS Vitrification Freeze kitcontained 9x1 mL. Vitrification solutionVSCatalog #90132
- Product formLiquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 9 x 1 mL Equilibration Solution- ES; 9 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 90133-DSOCKit- Vitrification Freeze kit: Which contained VS Vitrification solution, Lot/Unit numbers: 90132210403 — 00893727002811UDI # 00893727002811 901319 x1 mL Vitrification Solution, VS, Catalog #0132 and 9x1mL. Equilibration Solution, ES - Amount recalled
- 677 units or kits of 90133-DSOC210605 (9 x 1ml per kit); 595 kits in U.S. and 82 kits OUS
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to a component in kit being labeled with the incorrect Expiration Date
This product could cause temporary or reversible health problems — stop using it.
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