Class II — Fujifilm Irvine Scientific, Inc.
| Recalling firm | IRVINE SCIENTIFIC LLC |
|---|---|
| Registered facility | IRVINE SCIENTIFIC LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023). |
| Product | Sperm separation media are used to separate motile sperm from other constituents of semen. |
| Quantity | 246 |
| Distribution | US: OK, CA, DC, NC, NV, TX, MI, IN, NY, UT, WI, MN, PA, WV, NJ, IL, LA, WA, OR, FL, IA. OUS: GB, NL, AR, MY |
| Initiated | 2023-11-02 |
| Classified | 2024-02-06 |
| Recall number | Z-0998-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Fujifilm Irvine Scientific, Inc. (Z-0998-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93726/
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