# FDA recall Z-0248-2022

> **Fujifilm Irvine Scientific, Inc.** · Class II · device recall initiated 2021-09-08.

## 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 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 kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid.  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

## 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.

## Key facts

- **Recall number:** Z-0248-2022
- **Recalling firm:** Fujifilm Irvine Scientific, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-08
- **Report date:** 2021-11-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Ana, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0248-2022

## Citation

> AI Analytics. FDA recall Z-0248-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0248-2022. Source: US FDA. Licensed CC0.

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