Fujifilm Irvine Scientific, Inc. recalls Sperm separation media are used to separate motile sperm from other constituents of semen.
- Recall date
- November 2, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0998-2024
- FDA classification
- Class II
- Brand / firm
- Fujifilm Irvine Scientific, Inc.
- Sold / distributed
- 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
Why it was recalled
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).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sperm separation media are used to separate motile sperm from other constituents of semen.
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