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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II labeling error recall with no reported illnesses or injuries. An incorrect expiration date could result in use of expired materials, but this represents a labeling issue rather than a known material defect or safety hazard with documented harm.
Plain-English summary
Vit Kit-Freeze is a medical device used in assisted reproductive procedures to freeze and store human eggs (oocytes), pronuclear zygotes, cleavage-stage embryos, and blastocyst-stage embryos for future use. The kit contains specialized solutions intended to be used sequentially during a vitrification process.
Fujifilm Irvine Scientific, Inc. is recalling Vit Kit-Freeze kits because components in the kit were labeled with an incorrect expiration date. This labeling error could result in use of expired materials during reproductive procedures.
The recall affects 677 units: 595 kits distributed in the United States and 82 kits distributed internationally to Brazil, the European Union, Canada, India, South Korea, and Singapore. The affected kits can be identified by Lot/Unit number 90132210403.
The recalled product
- 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
- Manufacturer
- Fujifilm Irvine Scientific, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot/Unit numbers: 90132210403
- UDI # 00893727002811
- 9 x1 mL Vitrification Solution
- VS
- Catalog #0132 and 9x1mL. Equilibration Solution
- ES Catalog 90131
Distribution
Part of a larger recall action
This product is one of 2 recalled by Fujifilm Irvine Scientific, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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