Vitrification Freeze Kit Recalled Due to Incorrect Expiration Date Labeling
Fujifilm Irvine Scientific is recalling Vit Kit-Freeze due to incorrect expiration date labeling on a component. The incorrect label could lead to use of degraded solutions in assisted reproductive procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II medical device recall for a labeling error involving incorrect expiration date marking. No illnesses or injuries have been reported. The hazard is theoretical—incorrect labeling could lead to use of solutions beyond their actual expiration, potentially affecting efficacy, fitting the rubric category of 'Minor labeling errors.'
Plain-English summary
Fujifilm Irvine Scientific, Inc. is recalling Vit Kit-Freeze (Vitrification Freeze Kit), a medical device used in assisted reproductive procedures to preserve human eggs, zygotes, and embryos. Catalog number 90133-SO with lot number 90132210403 was recalled due to incorrect expiration date labeling on a component.
The incorrect label could result in use of solutions beyond their actual expiration date, potentially compromising their effectiveness for cryopreservation procedures.
The affected product was distributed to 33 U.S. states and internationally to Brazil, European Union countries, Canada, India, South Korea, and Singapore. A total of 3,981 units were distributed (314 in the U.S., 3,667 outside the U.S.).
Affected healthcare providers and patients should contact Fujifilm Irvine Scientific for guidance. Do not use the affected kits until the labeling issue is resolved or confirmed otherwise by the manufacturer.
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 (2)
- Catalog number: 90133-SO Vitrification Freeze kit Lot/Unit numbers: 90132210403
- UDI # 00893727002811 Product code MLQ
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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