Drug recall
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human…
FDA recall event 88720 · Class II · Fujifilm Irvine Scientific, Inc.
Key facts
| Event ID | 88720 |
|---|---|
| Recall numbers | Z-0248-2022, Z-0249-2022 |
| Recalling firm | Fujifilm Irvine Scientific, Inc. |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a component in kit being labeled with the incorrect Expiration Date |
| Initiation date | Sep 8, 2021 |
| Report date | Nov 24, 2021 |
| City | Santa Ana |
| State | CA |
| Country | United States |
| FEI number | 2022379 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: